Method and device for plaque disruption

Abstract

Balloon catheters, sleeves, cages, cylindrical structures, and intraluminal prostheses include stressing and spacing features coupled to their expandable surfaces. At least one or at least some of the stressing features may be immobilized on the surface or pre-formed into depressions formed within the expandable surface. The stressing and spacing features may have blunt and / or rounded contact areas that contact tissue or calcified areas within the vasculature. When expanded, the contact areas indent or disrupt obstructive material on the walls of the vessel lumen and / or the patient's valve leaflets. Spacing of the features may allow perfusion of blood, drugs, and contrast media through the expanded structures within the vasculature, particularly the balloon catheter.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This PCT application is based on the following provisional applications, the entire disclosures of which are incorporated herein by reference: U.S. Provisional Patent No. 63 / 409,419 (Attorney Docket No. 32016-726.105), filed September 23, 2022; U.S. Provisional Patent No. 63 / 411,095 (Attorney Docket No. 32016-726.106), filed September 28, 2022; U.S. Provisional Patent No. 63 / 421,940 (Attorney Docket No. 32016-726.107), filed November 2, 2022; U.S. Provisional Patent No. 63 / 421,940 (Attorney Docket No. 32016-726.108), filed December 8, 2022; This application claims the benefit of U.S. Provisional Patent No. 63 / 386,637 (Attorney Docket No. 32016-726.108), filed on December 15, 2022; U.S. Provisional Patent No. 63 / 387,636 (Attorney Docket No. 32016-726.109), filed on July 17, 2023; and U.S. Provisional Patent No. 63 / 514,079 (Attorney Docket No. 32016-726.110), filed on August 29, 2023.

[0002] In the United States, this non-provisional application is a continuation-in-part of U.S. patent application Ser. No. 17 / 863,265 (Attorney Docket No. 32106-726.301), filed July 22, 2022, which is a continuation-in-part of provisional application Ser. No. PCT / US2022 / 022213 (Attorney Docket No. 32106-726.601), filed March 28, 2022, the entire disclosure of which is incorporated herein by reference. Provisional Application No. 3 / 322,372 (Attorney Docket No. 32106-726.101), filed December 9, 2021, claims the benefit of Provisional Application No. 63 / 287,813 (Attorney Docket No. 32106-726.103), filed September 3, 2021, and Provisional Application No. 63 / 240,811 (Attorney Docket No. 32106-726.102), filed March 29, 2021.

[0003] The present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices comprising or consisting of expandable structures, including vascular devices, vascular catheters, expandable sleeves, expandable cages, balloon catheters, scaffoldings, stents, vascular grafts, implantable vascular prostheses, configured to open, dilate, deliver drugs to, and / or rupture calcified and / or hardened lesions within blood vessels and / or valves and / or body lumens. [Background technology]

[0004] Balloons, cages, stents, grafts, and other prosthetic devices are commonly used to provide or maintain patency within blood vessels and cardiac and venous valve structures that have been narrowed by lesions or other disease conditions. When lesions are hardened by plaque, calcium, and the like, a "cutting balloon" may be used for the initial treatment step, disrupting the plaque and calcification and allowing the balloon to widen the lesion prior to stent placement. Optionally, the stent may be post-dilated using a non-compliant angioplasty balloon to ensure good adhesion to the vessel wall. The post-dilation balloon is brought to a higher ambient pressure using a balloon inflation device. However, stent placement after angioplasty using a cutting balloon can be problematic in some respects, especially when followed by post-dilatation at higher pressures. In some cases, the vessel wall may be injured, or such injury may propagate. In others, debris generated by the cutting balloon may be released as emboli.

[0005] The use of cutting balloons, cutting cages, and cutting stents has been proposed to disrupt vascular calcification, but they are associated with various problems, including being poorly deliverable, tending to be bulky, limiting access, or causing patient injury. Cutting stents have been proposed for use in "primary stenting" procedures, which do not involve the use of a pre-dilation angioplasty balloon to widen the area to be stented. Primary stenting reduces or eliminates the need to perform two or three sequential interventions, which in turn reduces the risk of vascular injury and embolic release, as discussed above. However, cutting stents have similar limitations, such as being bulky, posing a risk of injury, and still being difficult to deliver.

[0006] Cardiac and venous valve function can be adversely affected by the presence of calcifications on valve leaflets. Valvuloplasty procedures rely on disrupting the lesion by expanding a balloon inside the opposing leaflet surfaces to crack the calcifications. The use of cutting and caged balloons to enhance such valvuloplasty procedures has been proposed but has not found widespread use due to the increased risk of damaging the valve and / or valve function.

[0007] Despite significant potential improvements in many instances, such cutting balloons, cages, and stents typically employ sharp blades that are oriented radially outward, presenting a risk of injury to the patient.

[0008] Additionally, the cutting blades make the device bulky, less deliverable, and can often limit access to distal vascular regions. The cutting blades also tend to rupture the vessel wall beneath calcified / hardened plaque lesions, especially at higher inflation pressures, which can result in patient injury.

[0009] Another challenge in performing angioplasty and valvuloplasty procedures is the temporary blockage of the vessel lumen or valve annulus due to balloon dilation. While temporary blockage of blood flow is often acceptable, a more serious concern can be loss of contrast agent flow downstream of the balloon. Even a brief loss of contrast agent can make fluoroscopic imaging of the procedure more difficult. Various perfusion catheters have been proposed, but they often require an additional flow lumen through the balloon, making the catheter larger and less useful in many situations.

[0010] A still further challenge with using known cutting balloons is that the elongated blades on the balloon make the balloon so stiff that it can be difficult to deploy in tortuous anatomy.

[0011] For these reasons, it would be desirable to provide improved methods and apparatus for opening, dilating, delivering drugs to, providing improved visualization of, and / or treating calcified or hardened lesions with reduced risk to patients and peers or improved effectiveness in treating calcified or hardened lesions. The improvements would preferably apply to a wide variety of vascular and cardiac devices, particularly plaque disruption balloon designs, including expandable structures such as vascular catheters, expandable sleeves, expandable cages, balloon catheters, stents, implantable vascular prostheses, drug delivery devices, and the like. It would be even more desirable if the devices and procedures improved the perfusion of both blood and / or contrast media during the procedure. In addition, it would be desirable to provide a plaque disruption balloon design with limited or no loss of flexibility due to the presence of plaque disruption elements on the balloon. At least some of these advantages will be provided by the present invention.

[0012] US 7,662,163 (Patent Document 1) describes an increased stiffness balloon device with one or more stiffeners having sharp and other protrusions thereon. US 2009 / 0105687, US 2006 / 0129229, US 2005 / 0137621, US 9370644, US 9119944, US 8992553, US 8882790, US 8523887, US 8323325, US 7799043, US 6197013, US 5242397, and EP 2919707, expandable scaffolds with plaque disruption and other features. Patents and printed publications describing the present invention include US8876882, US7494497, US9724121, US7731744, US5591197, US2006 / 122684, US2014 / 277562, US2001 / 037146, US2006 / 271161, US2020 / 0323545, US10143452, US9717513, US8398662, US Patents and printed publications describing multiple surface valvuloplasty include US2021 / 0378744, US11000299, US10758255, US10478202, US9827096, US8187223, US20210393281, US20200197033 No. 11000299, No. US10980553, No. US10342962, No. US10245419, No. US9504807, No. US9375555, No. US4986830, No. EP13526772, No. EP1480709, No. KR20200077682, No. WO2020014515, No. WO2012040225, No. WO2003 / 084594, and No. WO2013126779. Parent application No. US17 / 863,265 has been published as US2022 / 0338889 and WO2022 / 212290. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] U.S. Patent No. 7,662,163 Summary of the Invention [Means for solving the problem]

[0014] The devices according to the present invention comprise stress- or force-applying features, which may have any one of a variety of specific designs and geometries selected to rupture, depress, or otherwise fracture regions of calcified or otherwise hardened plaque, dilate, deliver drugs to, improve visualization of, and / or expand lesions within a patient's vasculature, with low to minimal risk to underlying patient tissue. The devices of the present invention will often find use in angioplasty, stent placement, drug delivery, enhanced visualization, and other interventions in the arterial or venous vasculature. Additionally, the devices of the present invention will find use in treating or modifying cardiac and venous valve structures, for example, when performing valvuloplasty procedures within a patient's aortic valve.

[0015] The phrase "stress-applying feature" is intended to encompass a variety of specific force-applying structures, such as plaque-fracturing features, plaque-engaging features, calcium-engaging features, etc., and these terms may be used interchangeably in this specification and claims. Other suitable descriptors for these features include plaque-subduction features and stress-inducing features, and unless otherwise stated, these terms and phrases will be used interchangeably. The stress-applying features of the present invention may have any one of a variety of designs as described herein.

[0016] A first type of stress-applying feature will typically comprise a blunt contact area configured to engage plaque or other hardened or calcified material and dilate, rupture, dent, or otherwise fracture that material while minimizing risk to underlying tissue or vessel wall, valve annulus, or other patient tissue that would be at risk if pressure were applied by a blade or other sharp structure. Various specific designs for stress-applying features of the present invention are described below and include disks, plates, balls, spheres, hemispheres, partial spheres, ellipsoidal solid bodies, ovals, etc., and the like. Stress-applying features may be solid or comprise hollow interiors. Stress-applying features of the present invention may be (1) pre-formed and attached to a device such as a balloon, sleeve, stent, or cage; (2) fabricated such that they are an integral or component part of a balloon, sleeve, stent, or cage, as described in further detail herein; or (3) a combination of (1) and (2).

[0017] The devices of the present invention will typically further comprise an apparatus or structure for radially advancing or deploying the stress-applying feature within a patient target site, such as a blood vessel, a valve annulus, or other body lumen or cavity. In some cases, the preformed stress-applying feature may be directly attached to or coupled to the outer surface of any one of a variety of expandable structures, such as a balloon, stent / scaffolding, stent, cage, sleeve, valve prosthesis, valvuloplasty balloon catheter, and the like. In other cases, the stress-applying feature may be directly fabricated as an integral part of such an expandable structure. In still other cases, the stress-applying feature may be attached or fabricated as part of an intermediate structure that is not itself configured to expand, but may be mounted or fabricated over a separate expandable structure. For example, the stress-applying feature of the present invention may be mounted or formed as part of a sleeve, sheath, cover, mesh, or other support structure that may be mounted to surround or otherwise be supported by an expandable structure, such as an elastic sleeve mounted over an expandable balloon.

[0018] Exemplary stress-applying features of the present invention will typically have a circumscribed "footprint" or base having a maximum length, width, diameter, or other dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less or 0.25 mm or less. In another example, the base of the stress-applying feature may have a length, width, diameter, or configuration ranging from 0.1 mm to 4 mm, preferably from 0.2 mm to 2 mm, and more preferably from 0.3 mm to 0.75 mm. Footprint refers to the dimension of the maximum coverage or contact area of ​​the stress-applying feature at the base over an underlying supporting surface, such as the exterior surface of a balloon, sleeve, scaffolding, cage, or stent. The contact or coverage area dimensions of the stress-applying feature may be equal to that of the base in the case of a disk, ball, sphere, etc., or may exceed that of the base when the feature tapers radially outward, as in the case of an inverted cone, inverted hemisphere, or inverted partial sphere, or may be smaller than that of the base when the feature tapers radially outward, as in the case of a cone, hemisphere, or partial sphere. In one example, the contact area of ​​the stress-applying feature may have a length, width, diameter, or configuration ranging from 0.01 mm to 4 mm, preferably ranging from 0.1 mm to 2 mm, and more preferably ranging from 0.1 mm to 0.75 mm. In another example, the stress-applying feature is spherical or equivalent, and the contact area and / or base have a length, width, diameter, or configuration ranging from zero or approximately zero to 0.1 mm, more often ranging from 0.001 mm to 0.1 mm. The stressing features of the present invention are typically not axially extending elongated members such as blades or similar elongated cutters, but rather will have circumferential and axial elongation or configurations that are approximately the same. In preferred embodiments, the footprint at the base of the stressing feature has a maximum axial length to maximum circumferential width ratio in the range of 0.5:1 to 1:0.5, more preferably 0.75:1 to 1:0.75, and most preferably about 1:1.In another preferred embodiment, the dimensions of the stress-applying features at their bases are substantially the same as the dimensions of the contact coverage area dimensions, as in the case of, for example, a ball, hemisphere, partial sphere, sphere, or square. Limiting the length of the stress-applying features in the axial direction (optionally maximizing the extent of the features in the circumferential direction) is advantageous because it reduces stiffness, maximizes the flexibility and bendability of the balloon, and facilitates insertion and removal within tortuous anatomy.

[0019] Preferred stress-applying features will comprise, consist essentially of, or consist of a rigid structure formed from a hard material, typically a metal or metal alloy. The rigid structure will have a convex upper rounded surface formed, for example, as a convex rounded upper apex, a convex upper apex, a convex rounded upper apex, or the like, typically having a radius of curvature ranging from 0.1 mm to 1 mm. The rigid structure may have any of a variety of geometries, such as a sphere, hemisphere, partial sphere, ellipsoid, semi-ellipsoid, partial ellipsoid, or similar geometry. Metals and / or metal alloys, particularly steel, stainless steel, tungsten, tungsten carbide, cobalt, cobalt chromium, platinum, are preferred materials, although other metals or metal alloys and other hard materials, such as minerals, ceramics, hardened polymers, etc., and / or the like, having a Mohs hardness greater than 4, preferably greater than 5, and more preferably greater than 6, may also be suitable for use. In other specific examples, the stress-applying features may comprise or consist of metals and / or metal alloys, including palladium, rhodium, titanium, and nickel.

[0020] The rounded convex upper surface of the stress-applying feature will typically have a radius of curvature ranging from 0.1 mm to 3 mm, preferably from 0.1 mm to 2 mm, more preferably from 0.1 mm to 1 mm, and most preferably from 0.1 to 0.5 mm. The radius will be uniform for spherical, hemispherical, and partially spherical convex surfaces. In contrast, the radius of curvature will typically vary for non-spherical, e.g., ellipsoidal, asymmetric, or irregular convex upper surfaces, where at least one side of the upper surface will have a radius of curvature ranging from 0.1 mm to 3 mm, preferably from 0.1 mm to 2 mm, more preferably from 0.1 mm to 1 mm, and most preferably from 0.1 to 0.5 mm, and will have various types of shaped bases, such as asymmetric, irregular, or non-circular bases, or, in rare cases, circular or symmetric bases. The base of such a non-circular or irregular shape may have a maximum:minimum dimension ratio (e.g., length to width ratio) of 5:1 or less, typically 3:1 or less, and more typically 1.9:1 or less, where the length is oriented circumferentially on the outer balloon surface while the width is oriented axially on the outer balloon surface. Similarly, the upper surface of a non-circular or irregular shape may have a maximum:minimum dimension ratio (e.g., length to width ratio) of 5:1 or less, typically 3:1 or less, and more typically 1.9:1 or less, where the length is oriented circumferentially on the outer balloon surface while the width is oriented axially on the outer balloon surface. The upper surface typically refers to the top region of the feature.

[0021] The rounded, convex upper surface of the stress-applying feature will typically be smooth, with few or no irregularities or anomalies. The surface may be formed or processed to be smooth and rounded, for example, by casting, molding, machining, or other standard processing methods. Alternatively, a smooth, rounded surface can be formed by coating, sputtering, or otherwise depositing a harder material, such as a metal, over a core structure attached to the outer balloon wall surface. In certain other cases, a smooth, rounded surface can be formed by coating, sputtering, or otherwise depositing a material, such as a metal / metal alloy, polymer, ceramic, or other material, that will cover a core structure attached to the outer balloon wall surface and render the upper surface smooth, rounded, convex, or atraumatic.

[0022] The stress-applying features are typically molded, machined, or otherwise formed into their preferred spherical, hemispherical (including partial spherical), ellipsoidal, semi-ellipsoidal (including partial ellipsoidal), or similar shape, have a base configured for direct attachment to the outer balloon surface, and are usually flat or slightly concave, or contoured to conform to the outer balloon surface, as described elsewhere herein. The stress-applying features are typically formed as a monolithic structure, with no internal seams or splits separating the stress-applying feature into two or more components that are attached to each other and form the feature, and the feature is attached to the outer surface of the balloon. In other cases, however, the stress-applying feature is formed into a sphere, hemisphere (including partial sphere), ellipsoid, semi-ellipsoid (including partial ellipsoid), or similar shape by joining two or more sections, each section formed separately and then joined together after processing or attachment to the outer balloon surface to form the feature shape, so long as the desired sphere, hemisphere, partial sphere with a convex apex, ellipsoid, semi-ellipsoid, partial ellipsoid with a convex apex, or similar shape is maintained. That is, the base section (attached to the outer balloon surface) has a configuration or shape and size that is equal to or larger than the maximum cross-sectional configuration or size and shape of the upper region of the feature.

[0023] The stress-applying and other rigidity features of the present invention may be monolithic, i.e., have a continuous, typically homogeneous structure, usually formed by molding, machining, casting, or other conventional processes. However, in other cases, the stress-applying and other rigidity features of the present invention may be "polylithic," comprising, consisting of, or consisting essentially of two or more different parts, sections, elements, laminates, coatings, attachments, and the like, often comprising a base and an upper region or section. The base may comprise parts or slices of features, for example, in horizontal or vertical planes, attached or integrated together to form a structure, preferably having a convex upper smooth surface, more preferably having a smooth rounded convex upper surface without an atraumatic portion.

[0024] In some cases, such a structure includes a base and an upper section, and the periphery of the base preferably does not protrude beyond the periphery of the upper section, i.e., no edge is formed.

[0025] In some cases, the base smoothly transitions or "contours," with the feature upper section and / or slice of the feature being joined together by adhesive or welding to form a smoothly rounded feature. Such features may be formed from any one or more of the materials described elsewhere herein, including, but not limited to, polymeric, ceramic, or mineral materials.

[0026] Such features may have one or more convex upper surfaces, rounded upper surfaces, or the like, which may have a radius of curvature in at least one direction within the range of 0.05 mm to 0.5 mm, preferably 0.05 mm to 0.25 mm. At least one upper surface is preferably convex, rounded, smooth, or otherwise atraumatic so as not to cause injury to non-calcified lesions and healthy vessel walls. Exemplary stress-applying and other rigidity features include spherical, hemispherical, and partially spherical shapes with rounded upper surfaces.

[0027] The features, particularly the upper rounded or other sections of the features, may initially be formed or processed to have a smooth surface, or may initially be formed or processed to have a rough or otherwise irregular surface and smoothed after the initial processing, for example, by coating or sputtering with the same or another material. In preferred cases, the features may be coated with a harder material.

[0028] In some cases, features having sharp, penetrating, or other exposed "traumatic" elements may be covered, coated, polished, or otherwise modified to provide both traumatic and atraumatic regions on the upper section or elsewhere on the element for therapeutic purposes. For example, a cutting, penetrating, or other traumatic element may be enclosed within and / or surrounded by a rounded, convex, and / or smooth upper surface region such that the traumatic element will fracture calcium, while the surrounding atraumatic surface will prevent injury to adjacent plaque. The surrounding covering will typically be softer than the feature's traumatic element and will allow the traumatic element to protrude or exert force through the surrounding softer region when expanded against calcified plaque or the vessel wall. Alternatively, such traumatic elements or components of a feature may protrude or exert a force when an adjacent, softer covering is pressed against the vessel wall, causing the surrounding covering to compress and allowing the traumatic elements to protrude and engage hardened plaque on the vessel wall. In other cases, the surrounding covering may be formed from a hard material that does not compress when pressed against the vessel wall. In those cases, the traumatic elements may be configured to fixedly protrude from the covering such that the elements will engage the vessel wall before the surrounding covering engages the vessel wall.

[0029] Exemplary stress-applying features of the present invention also typically have a height, measured from a base attached to a support surface or substrate to the contact coverage area (contact area), typically at least 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, or greater than 0.25 mm, and often not more than 1 mm, not more than 0.5 mm, not more than 0.4 mm, not more than 0.3 mm, not more than 0.25 mm, not more than 0.15 mm, not more than 0.1 mm, and less than 0.1 mm, including all ranges of minimum and maximum recited heights. In preferred embodiments, feature heights range from 0.1 mm to 1 mm, preferably from 0.2 mm to 0.75 mm, and more preferably from 0.25 to 0.5 mm. Features may have the same height along the entire structure or different heights along the circumference and / or axial length of the substrate.

[0030] In preferred embodiments, the stress-applying features are discrete features that enhance the flexibility and deliverability of the device within a patient's vasculature or body lumen. Such discrete stress-applying features typically comprise 0.005 to 20 features / mm of the outer balloon surface when inflated or otherwise expanded. 2 , preferably 0.005 to 5 features / mm 2 , more preferably 0.01 to 5 features / mm 2 , typically 0.01 to 3 features / mm 2 , more typically 0.01 to 1 features / mm 2 , most typically 0.01 to 0.1 features / mm 2 The particles will be distributed over the expandable surface at a density of .mu.m.

[0031] In addition to maintaining feature density, and to improve the flexibility and bending of the balloon as it is introduced through the vasculature, it may be preferable to maintain a minimum axial spacing between circumferentially adjacent stress-applying feature bases or between all stress-applying feature bases along the circumference of the expandable balloon when expanded. In particular, the minimum axial distance between circumferentially adjacent stress-applying feature bases (or between all stress-applying feature bases along the circumference of the expandable balloon) should be at least 0.05 mm, preferably at least 0.1 mm, while the maximum axial spacing will be 3 mm, usually 2.5 mm, with spacing typically in the range of 0.05 mm to 3 mm, more typically 0.1 mm to 1 mm.

[0032] In a preferred embodiment, at least one section or at least one region of the expandable structure outer surface (or the expandable balloon outer surface) has a surface area of ​​0.01 to 0.1 features / mm of the outer surface when the balloon is inflated or otherwise expanded. 2 and all circumferentially adjacent stress-applying features along the circumference of the expanded structure (or inflated balloon outer surface) have a minimum axial spacing between their bases ranging from 0.05 mm to 2 mm, and the stress-applying feature upper surfaces have a radius of curvature ranging from 0.1 mm to 1 mm.

[0033] In preferred embodiments, the stress-applying features are discrete, independent, and / or separated from one another to improve flexibility and deliverability of the device within a patient's vasculature or body lumen. Such stress-applying features typically have a density of 0.1 to 20 features / mm when inflated or otherwise expanded. 2 , preferably 0.1 to 5 features / mm 2 , more preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2In a preferred embodiment, the features each apply an independent or focused force to plaque, vessel wall, tissue, hardened plaque, or calcified lesion.

[0034] In preferred embodiments, the stress-applying features are discrete and the feature contact area, body, and / or base are each blunt, rounded, smooth, and / or atraumatic to enhance flexibility and deliverability of the device within a patient's vasculature or body lumen. Such stress-applying features typically have a density of 0.1 to 100 features / mm when inflated or otherwise expanded. 2 , preferably 0.1 to 20 features / mm 2 , more preferably 0.1 to 5 features / mm 2 or in some cases, 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 In another example, the features comprising the contact region, base, and body are rounded, blunt, and atraumatic, allowing for fracture, depression, or expansion of hardened and / or calcified plaque while improving flexibility and deliverability of the device within a patient's vasculature or body lumen.

[0035] In yet another embodiment, the stress-applying features are coated with one or more materials to provide roundness, a smooth surface, bluntness, and / or an atraumatic surface, and improve the flexibility and deliverability of the device within a patient's vasculature or body lumen while being able to fracture, dent, or expand hardened and / or calcified plaque. In preferred embodiments, the material comprises one or more of a metallic material, a ceramic material, a polymeric material, an adhesive material, a hydrophilic material, and the like. The material is deposited, soldered, coated, plated, dipped, heat-treated, hardened, or otherwise applied to the surface of the stress-applying feature. The material may be degradable or non-degradable in a physiological environment. In yet another example, the coating material provides an additional means of attachment of the stress-applying feature to the expandable structure surface, the coating covering the feature and portions of the expandable structure surface adjacent to the feature.

[0036] In preferred embodiments, at least a majority, and preferably all, of the surface of the stress-applying feature exposed above the exterior of the expandable member or other support surface will be free of irregularities and imperfections that may inhibit advancement through the target body lumen, and will be rounded and typically configured to present an edge-free, low-friction, smooth surface to the wall of the vasculature or other body lumen as the expandable structure is advanced therethrough. "At least a majority" means that at least 50%, preferably at least 60%, more preferably at least 70%, even more preferably at least 80%, and most preferably at least 90% of the exposed surface of the stress-applying feature will be rounded, smooth, edge-free, or otherwise configured to present low friction. It has been found by the inventors herein that such smooth, rounded features, when deployed as described herein, will still be capable of providing the force necessary to dent / fracture even hardened plaque.

[0037] Preformed stress-applying features according to the present invention may be attached to an expandable or non-expandable support structure, typically an expandable structure, e.g., a polymer balloon, or an intermediate structure, e.g., a scaffold, sleeve, or cage, by one or more of the following: solder, adhesive (glue), typically the use of acrylic or other polymer adhesives, thermal bonding, fusion, welding, threaded attachment, riveting, crimping, interference fit, etc., and the like. Stress-applying features integrally formed as part of a balloon, scaffold, stent, cage, or sleeve may occur in a later or final process or location, e.g., by molding, i.e., a deposition process to build a structure onto the outer surface of the scaffold, balloon, or sleeve, or, in a preferred alternative, may be formed as tabs or other elements protruding from a component of the scaffold, such as a crown, strut, or link, and folded over the outer surface of the component after the scaffold is formed but before implantation. Specific examples of such features are described in more detail herein as accessory features. Preformed stress-applying features according to the present invention may be attached to an expandable structure, e.g., a balloon, or an intermediate structure, e.g., a scaffold or sleeve or cage, by one or more of soldering, the use of adhesives (glues), thermal bonding, fusing, welding, threaded attachment, riveting, crimping, interference fit, etc., and the like. Stress-applying features integrally formed as part of a balloon, scaffold, stent, cage, or sleeve may occur in a later or final process or location, e.g., by molding, i.e., a deposition process to build a structure onto the outer surface of the scaffold, balloon, or sleeve, or, in a preferred alternative, may be formed as tabs or other elements protruding from a component of the scaffold, such as a crown, strut, or link, and folded over the outer surface of the component after the scaffold is formed but before implantation. Different individual stress-applying features on a single support structure may have the same or different footprints, shapes, heights, configurations, and the like, so that adjacent stress-applying features may be the same or different. Specific examples of such features are described in further detail as accessory features herein.

[0038] In many cases, it will be preferable to select polymer adhesives and other polymer layers formed over the outer wall surface of an inflatable polymer balloon that have a hardness that is less than the hardness of the balloon polymer or other material. Lower hardness typically corresponds to greater compliance. In a preferred embodiment, the inflatable balloon, once cured, has a Shore D hardness in the range of 60D to 80D (typical for nylon), and the polymer adhesive has a Shore D hardness in the range of 50D to 65D (typical for acrylic). For comparison, rigid stress application features will typically have a Mohs hardness greater than 4, usually greater than 8.

[0039] In preferred embodiments, the expandable structure comprises one or more of an inflatable polymer balloon, a stent, a sleeve, a cage, a drug delivery balloon, or the like. The stress-applying features may be applied to one or more surfaces or surface regions of the expandable structure, and the surfaces may comprise the outer surface, the inner surface, and the side surfaces of the expandable structure. When the features are applied to the inner surface of the expandable structure, they protrude radially outward and engage the hardened plaque in response to expansion or inflation of the expandable structure.

[0040] In some cases, stress-applying features may be applied to one or more outer surface regions of an inflatable polymeric balloon, such as the working length of the balloon (typically a central region of a cylindrical or other tapered or non-tapered tubular surface of the polymeric inflatable balloon) and / or a conical or other tapered end region of the balloon. Additionally or alternatively, stress-applying features may be applied to opposing sidewalls or surfaces, such as those formed by gaps or annular depressions created in the wall of the inflatable polymeric balloon, configured to capture valve leaflets for performing valvuloplasty, as described in detail herein below.

[0041] As used herein and in the claims, the phrase "outer surface" of an inflatable polymeric balloon includes both the outer surface of the inflatable polymeric balloon itself and any outer surface of a base or other layer formed over and fixedly attached or adhered to the outer surface of the inflatable polymeric balloon. For example, the phrase "outer surface" of an inflatable polymeric balloon specifically includes the outer surface of any underlying layer formed over the underlying balloon wall, which may comprise, consist essentially of, or consist of one, two, three, or more than three sheets, coatings, or films applied simultaneously or sequentially.

[0042] In certain cases, stress-applying features may be at least partially affixed to the expandable structure, e.g., on the crowns and / or struts, to the outer surface of one or more elements of the scaffold rings. Such features can also be at least partially affixed to the connectors, which connect two adjacent rings of the scaffold. The stress-applying features can be formed from the same material as the scaffold, or from a different material or materials. The stress-applying features can be 3D printed (deposited) or laser cut from a tube, either separately from the scaffold fabrication or as part of the scaffold fabrication. In either case, the stress-applying features project radially outward from the scaffold elements, such as the crowns, struts, or connectors. The stress-applying features may be formed as part of the scaffold and positioned in place after formation and before implantation, for example, as described above, by soldering, welding, adhesives (such as epoxies), interference fits, mechanical interlocks, bonding, or other techniques; the stress-applying features may be fixed or attached to the outer surface of the scaffold, or optionally positioned within recesses, holes, or other receptacles formed in or through the outer surface of the scaffold.

[0043] Attachment of the stress-applying feature may comprise one or more of coating, adhesive, fusing, solder, welding, vapor or chemical deposition, laser deposition, constriction with a sleeve, interference fit or mechanical locking onto the outer surface of the scaffold (onto a scaffold surface, recess, or hole indented through the scaffold into or through which a portion of the stress-applying feature is forced), epoxy, or a combination thereof, or others.

[0044] The scaffold can be formed from a degradable or non-degradable material. In preferred embodiments, a scaffold formed from a metal or metal alloy or other non-degradable material has a Mohs hardness of 2.5 or greater, preferably 3.5 or greater, and more preferably 4.5 or greater. In preferred embodiments, the stress-applying feature will have a Mohs hardness equal to or greater than the Mohs hardness of the scaffold or other expandable structure. In other preferred embodiments, the stress-applying feature will have a Mohs hardness greater than the Mohs hardness of the scaffold or other expandable structure. For example, the stress-applying feature may be formed from a material having a Mohs hardness in the range of 2-10, typically 2.5-10, more typically 3-10, 3.5-10, 4-10, 4.5-10, 5-10, 5.5-10, 6-10, or 6.5-10.

[0045] In preferred embodiments, the expandable structure comprises stress-inducing features having a Mohs hardness of 2.5 or greater, preferably 3.5 or greater, more preferably 4.5 or greater, often 5.5 or greater, and most preferably 6.5 or greater. In yet other embodiments, the stress-inducing features have a Mohs hardness ranging from 2 to 9, preferably ranging from 3 to 9, and more preferably ranging from 4 to 9. In yet other embodiments, the Mohs hardness of the stress-applying features will exceed the Mohs hardness of the expandable structure supporting the features.

[0046] In preferred embodiments, stress-applying features, spacer features, and all other protruding features and elements as described herein comprise at least one material from the following list: metal, polymer, ceramic, glass, metal alloy, or the like. At least one material may be coated with another material. For example, a stainless steel hemisphere may be coated with an adhesive and / or polymer material, where the adhesive and / or polymer material has a Mohs hardness less than that of the stainless steel hemisphere. In preferred embodiments, the stress-applying features comprise a metal or other hard core, as disclosed above, partially or completely covered by a coating, where the coating preferably has a Mohs hardness less than that of the core. A softer coating can provide any one of roundness, bluntness, lubricity, smoothness, and the like, without sacrificing the ability of the stress-applying feature to dent or rupture hardened plaque. In yet another embodiment, the Mohs hardness of the stress-applying feature will exceed the Mohs hardness of the expandable structure supporting the feature by at least two times. In a preferred embodiment, the expandable structure comprises or consists of a polymeric material, while the stress-inducing feature comprises or consists of a metal or metal alloy material.

[0047] In further preferred embodiments, the stressing features, spacer features, and all other protruding features and elements as described will inherently possess some degree of radiopacity, as is the case with many metals, either as a result of combination with, alloying with, plating with, or coating with radiopaque materials or fillers, or both, to aid in visualization under fluoroscopy. Suitable radiopaque fillers suitable for combination with polymers include salts or particles comprised of tungsten, gold, platinum, iridium, bismuth, barium, and / or iodine salts. Suitable metal or plated metal and non-metal features with high radiopacity for coating include bismuth, gold, platinum, tungsten, and iridium.

[0048] In other examples, the core may be polymeric and coated with a metallic coating having a Mohs hardness greater than that of the polymer characteristic. A specific combination of core and coating Mohs hardness may be selected to provide sufficient force to indent, fracture, or otherwise dilate hardened or calcified tissue or lesions, while remaining sufficiently flexible and smooth to be safely advanced through the vasculature or other biological structures.

[0049] When layering or mixing multiple adhesives, one adhesive material may be softer than the adjacent material. Alternatively, or in addition, a first adhesive material may be more compatible with the expandable member material and layered directly over the member surface, while one or more additional materials may be layered over the first layer to provide bonding with the stress-applying feature or other properties and improve the overall bonding of the stress-applying feature and the expandable member.

[0050] The material of the stress-applying feature is typically selected and configured to compress by 0.2 mm or less, 0.1 mm or less, 0.05 mm or less, and / or 0.01 mm or less when deployed against a calcification or other plaque by a balloon, sleeve, or other expandable member. In other words, the material compressibility against a rigid surface when pressurized through the expandable structure ranges from 0.001 mm to 0.2 mm, preferably 0.001 mm to 0.1 mm, and more preferably 0.001 mm to 0.01 mm. In other embodiments, the stress-applying feature has a material compressibility that is less than the compliance of the material of the expandable member when pressurized to a nominal inflation pressure.

[0051] In another embodiment, the stress application characteristic is at least 10 MPa m 1 / 2 , preferably at least 20 MPa m 1 / 2 , more preferably at least 50 MPa m 1 / 2 , most preferably at least 100 MPa m 1 / 2In a preferred embodiment, the stress application characteristics are a Mohs hardness greater than 4 and a fracture toughness greater than 50 MPa m 1 / 2 In a preferred embodiment, the stress-applying feature is made of a metal or metal alloy. In a preferred embodiment, the stress-applying feature is made of or comprises a radiopaque material that provides radiopacity under x-ray / fluoroscopy. In yet another embodiment, the stress-applying feature is made of or comprises a radiopaque material configured to provide radiopacity sufficient to visualize the feature under fluoroscopy, preferably sufficient to visualize the feature under fluoroscopy without the aid of a radiopaque contrast material. In yet another preferred embodiment, the stress-applying feature is attached to the outer surface of the expandable balloon catheter, and the feature is made of or comprises a radiopaque material configured to provide radiopacity sufficient to visualize the feature under fluoroscopy, the visualization being equal to or greater than that of a contrast-filled balloon under fluoroscopy. These advantages include providing precise sizing of the vessel, improved demarcation of expandable structures such as dilated / inflated balloons, and / or improved detection of hardened plaque or plaque morphology.

[0052] The stress-applying features of the present invention, when expanded by the expandable member, present a generally rounded, blunt, and atraumatic structure above the surface of the expandable structure to facilitate advancement through the vasculature, while still providing the force necessary to depress / fracture hardened plaque. This is advantageous because many of the prior art cutting features are sharp and would catch on the vasculature as the catheter is advanced. Thus, in preferred embodiments of the present invention, at least the entire surface above the substrate (sometimes including the feature surface attached to the substrate) is rounded and smooth to present minimal friction as it is advanced.

[0053] In another embodiment, the stress-applying features of the present invention present a generally rounded, blunt, peripheral-edge-free, and atraumatic structure above the surface of the expandable structure that, when expanded by the expandable member, still provides the necessary force to indent / fracture hardened plaque while facilitating advancement through the vasculature. In another embodiment, the stress-applying features of the present invention present a generally rounded, blunt, peripheral-edge-free, rounded (beveled) peripheral-edge-free, and atraumatic structure above the surface of the expandable structure that, when expanded by the expandable member, still provides the necessary force to indent / fracture hardened plaque while facilitating advancement through the vasculature. The plaque-fracturing features may also have peripheral edges or rounded (beveled) peripheral edges in another embodiment. However, in a preferred embodiment, the stress-applying features are peripheral-edge-free. In yet another preferred embodiment, the stress-applying features may be peripheral-edge-free or peripheral-beveled.

[0054] In some cases, stress-applying features of the present invention may comprise a sharp or potentially traumatic core that is covered or coated with another material that provides a rounded, blunt, or otherwise atraumatic engagement surface to avoid injury to the vasculature or other body lumen as the expandable member is advanced therethrough. In such cases, at least the potentially traumatic contact area of ​​the feature is covered or coated.

[0055] Expandable structures, such as balloons or scaffolds, can have any one of a variety of shapes or configurations, including one or more of the following: cylindrical, generally cylindrical, hourglass, dog-bone, tapered, elliptical, oval, or other shapes, external shapes, profiles, or configurations. In many cases, the balloon, sleeve, cage, or scaffold will be expandable from a crimped or small configuration to an deployed or larger configuration by applying an internal expansion force, typically by fluid or balloon expansion as commonly employed for vascular devices and stents. Alternatively, the scaffold can be constrained and deployed from the constrained configuration by removing or withdrawing the constraint. The constraint may be provided by a catheter, sleeve, sheath, or other conventional or novel constraining structure. Such designs are commonly referred to as "self-expanding."

[0056] The stress-applying features can be formed from one or more of the following materials: metals, metal alloys, ceramics, minerals, polymers, polymer hybrids, polymer blends, epoxies, diamond, or combinations thereof, including both degradable and non-degradable materials. Suitable metals and metal alloys include stainless steel, cobalt chromium, platinum chromium, platinum iridium, silver, nickel-titanium alloy (NiTi), tungsten, tungsten carbide, palladium, cobalt, gold, platinum, iridium, titanium carbide, zirconium, chromium, magnesium or magnesium alloys such as magnesium-zinc and magnesium-yttrium, zinc or zinc alloys such as zinc-calcium and zinc-lithium, and the like. In a specific embodiment, particularly useful when placing over balloons and sleeves, a chrome-plated steel ball may be used, which is corrosion-resistant and harder than the underlying metal, typically having a hardness comparable to that of a solid chrome ball.

[0057] In some embodiments, the plaque disruption feature comprises one or more materials that coat, cover, plate, or otherwise attach to one or more of the feature contact region, feature base, and / or feature exterior surface. In preferred embodiments, the material provides one or more of the following to the surface of the feature, base, or contact region: rounded, blunt, smooth, slippery, frictionless, convex, atraumatic surface, and / or lubricious. In some examples, the material is a polymer including one or more of polyparaxylylenes, e.g., Parylene, Parylene N, and Parylene C; silicones, e.g., polydimethylsiloxane, poly(diphenyl)siloxane, poly(methyl-co-phenyl)siloxane, poly(methyltrifluoropropyl)siloxane, poly(methyl-co-methyltrifluoropropyl)siloxane, or equivalents; polyurethanes and their copolymers, e.g., Tecoflex, Pellethene, Clonoflex, Clonoprene, Clonocene, Clonosil, polymer hybrids, or equivalents; polyethylene vinyl acetate; polyvinylidene fluoride; polyvinylidene fluoride-co-hexafluoropropene; polybutyl methacrylate; poly(styrene-butadiene-styrene); polylactide; hydrophilic materials; or equivalents; or combinations thereof. Examples of metals or metal alloys for coating include, for example, titanium, Ti-6Al-4V alloy, titanium-magnesium, stainless steel, e.g., 316, 304, 420, or equivalents, magnesium alloys, e.g., yttrium-zirconium-magnesium, chromium, cobalt, cobalt-chromium, CoCrMo, nitinol, tungsten, gold, platinum, silver, zinc, palladium, iridium, ruthenium, rhodium, indium, tin, molybdenum, iron, vanadium, nickel, niobium, zirconium, or equivalents, or combinations thereof, used to apply a hard or harder surface to a polymer feature by evaporation, sputtering, vapor deposition, or plasma coating onto the surface of the feature to provide a smooth, rounded, convex, and / or blunt surface.Examples of polymeric features that are rigidified by filling with fine glass, quartz, or silica fibers or particles, such as 40% glass-filled nylon, carbon fibers, carbon nanospheres, carbon nanotubes, carbon nanofibers, carbon nanotubes, talc, aramid, or the like, are other examples.

[0058] In preferred embodiments, adhesives are used to attach, coat, adhere, bond, and / or join the features or feature bases to the expandable structure surface. Examples include, but are not limited to, light-curable materials such as Henkel Loctite 3943, 3973, 3972, 3321, 3311, 3526, Permabond UV610, UV670, UB7141, or equivalents, moisture-resistant light-curable materials such as Loctite EA3335, 4310, 3525, 3494, or equivalents, epoxies such as 5 Minute Epoxy, Epo-tek MED-353ND, Epo-tek MED-HYB-353ND, Masterbond EP41SMed, Henkel Loctite 3981, polyurethanes such as Permabond PT321, PT326, and PT328, epoxy-polyurethane hybrids, and cyanoacrylates such as HB Fuller M2240-05, Permabond ET5393, Permabond 2011, Infinity The adhesive may include one or more of CA-110-M, Loctite 4014 (with or without a primer, e.g., HB Fuller 6070 or Loctite 713), structural acrylic adhesives such as Permabond TA430, TA435, TA437, TA49, TA459, TA4246 (with or without initiator 41 or 46), or the like, or combinations thereof. In preferred embodiments, the adhesive material covers at least a footprint the size of the footprint of the feature (or feature base) that contacts the expandable structure surface, a footprint larger than and including the footprint of the feature or feature base that contacts the expandable structure surface, at least some of the feature surface above the expandable structure surface, or at least the entire exterior surface of the feature. In yet another embodiment, the adhesive coats at least the interior surface of hollow features.

[0059] In a preferred embodiment, the stress-applying features include blunt contact areas that act to concentrate the force applied to occlusive material, resistive material, plaque, or calcified plaque on or within the wall of a blood vessel as the expandable structure or scaffold expands within the blood vessel or other body lumen.

[0060] In a preferred embodiment, the plaque disruption feature contact area is symmetric. The symmetric configuration provides smooth navigation through the vasculature without causing suspension or vascular injury. In another embodiment, the plaque contact area is asymmetric.

[0061] An individual stress-applying feature will typically possess a single blunt contact area, but in some cases may possess two, three, or more than three separately formed blunt contact areas, each defined by a continuous peripheral boundary. An individual blunt contact area is typically within 0.0001 mm. 2 ~5mm 2 , preferably 0.001 mm 2 ~2mm 2 , more preferably 0.001 mm 2 ~0.2mm 2 , most preferably 0.01 mm 2 ~0.2mm 2 In one example, the total outer surface area of ​​the sinusoidal scaffold ring or balloon will typically be in the range of 0.05 mm 2 ~10mm 2 , preferably 0.5 mm 2 ~2.5mm 2 , more preferably 0.5 mm 2 ~1.5mm 2 Depending on both the total number of blunt contact areas and the contact area of ​​each individual blunt contact area, the force (pressure) per unit area applied by the stress application feature will be increased by a factor in the range of 1 to 1,000, often 1 to 100, and preferably 1 to 50.

[0062] The radial distance of the blunt contact region of the stress-applying feature above the outer surface of an expandable structure, such as a scaffold or other structure, may be in the range of 0.05 mm to 1 mm, preferably 0.15 mm to 0.5 mm. The blunt contact region may have a width or diameter (for a circular blunt contact region) ranging from 10 μm to 2.5 mm, preferably 30 μm to 250 μm. In some cases, the blunt contact region may have a width-to-length ratio in the range of 1:3 to 3:1, often 1:2 to 2:1, and about 1:1, and is often circular.

[0063] Stress-applying features will typically be positioned directly across the outer surface of the scaffold, i.e., the features will be integrally formed and then deposited or otherwise positioned to extend or protrude radially away from the outer surface of the struts, crowns, links, or other primary components of the scaffold. However, in other cases, the stress-inducing features can be integrally formed, but the scaffold's accessory components have, for example, arms or other integral connectors (similar to links between adjacent rings) extending from the features and connecting to the primary scaffold elements. Examples include stress-applying features attached to scaffold crowns, struts, or links by arms. In some examples, a single accessory stress-applying feature may be attached to two or more primary scaffold components (e.g., crowns, struts, or links) by two or more individual arms.

[0064] Such accessory stress-applying features can be formed with blunt contact areas that protrude radially outward and can be useful in further reconfiguration or deformation. In this manner, the blunt contact areas can be positioned laterally, away from the outer surface of the primary scaffold component. In other cases, accessory features can be folded, typically by bending them over so that the attachment arms overlie the outer surface of adjacent primary scaffold components. Optionally, such folded accessory features can be further attached to the primary component by any of the techniques described above, such as soldering, welding, gluing, interference fit, mechanical interlocking, bonding, or other techniques.

[0065] In some examples, stress-applying features are located on substantially opposing surface regions on an expandable structure, such as a balloon surface or scaffold circumferential rings, such as on opposing crowns and / or struts, i.e., separated by 180°. In other examples, individual stress-applying features may be distributed around the circumference of a balloon, sleeve, cage, or individual ring at other equal angular separations, e.g., 30°, 45°, 60°, 90°, or 120°, and are typically located on the surfaces of crowns, struts, axial links, or bridges of two or more of such scaffold structures. In these and other cases, stress-applying features on an expandable structure or individual ring may be circumferentially offset from those on the axial length or one or more axially separated rings, e.g., by about 10°, 20°, 30°, 40°, 60°, or 90°. In still further examples, stress-applying features may be arranged in a helical pattern along a partial or entire length of the expandable structure or scaffold. In other examples, stress-applying features on an expandable structure, stent, or individual rings may be circumferentially and axially offset from one another within the structure, stent, or ring, and / or may be circumferentially and axially offset from those on a region of the expandable structure or from one or more other rings. In yet another example, at least one end of the expandable structure or scaffolding may have fewer or no stress-applying features (compared to the central structure or scaffolding region) over at least one, two, three, four, five, six, or more than six terminal lengths, as measured in mm or cm, or circumferential rings on one or both ends of the scaffold, and often no stress-applying features over these terminal ends or end rings.

[0066] In preferred embodiments, stress-applying features may be located only on the crown regions; stress-applying features may be oriented circumferentially around the surface of some or all of the individual rings; the number of stress-applying features per ring may range from 1 to 5, preferably 2 to 5, and more preferably 2 to 3; stress-applying features may be located only on the crown regions, only on the junction regions, or only on the crown and junction regions; stress-applying features may be located only on diametrically opposed crown regions, only on diametrically opposed junction regions, or only on diametrically opposed crown and junction regions; or stress-applying features may be located only on crown regions, junction regions, or crown and junction regions that are circumferentially separated by 30°, 45°, 60°, 90°, 120°, or 180°, on the same ring, or on axially adjacent or separated rings. In still other embodiments, stressing features may be present within individual circumferential rings with a ratio of "stressing features" to "crowns" ranging from 1:1 to 1:4, often between 1:2 and 1:3.

[0067] The stress-applying features of the present invention may have any one of a variety of specific shapes and configurations characterized by a blunt contact area at a location spaced radially outward from the outer surface of the expandable structure or scaffold. For example, they may have a disk-like shape, a truncated cone-like shape, a sphere-like shape, a ball-like shape, an elliptical shape, a truncated prismatic shape, a truncated teardrop-like shape, or the like. The base of the stress-applying feature may contact the outer surface of the expandable structure or scaffold, with a footprint having an elliptical, triangular, circular, polygonal, or irregular perimeter, and the blunt end positioned radially outward from the outer surface of the expandable structure or scaffold. In some cases, the stress-applying feature may be attached to a base layer, which is affixed to the outer surface of the expandable structure or scaffold, and one, two, three, or more than three additional layers may be formed or attached over the base layer. The layers can be formed from the same or different materials, can be applied or deposited in situ or pre-formed and attached by any of the methods described above, and can have the same or different shapes, lengths, widths, or heights. The stress-applying features will typically be symmetrical, but in some cases may be constructed asymmetrically with respect to circumferential and / or axial lines or planes.

[0068] The blunt contact region will typically be circular, but in some cases may be square, rectangular, polygonal, and / or elongated in the axial or lateral directions. For example, the blunt contact region may have a length and width, with an aspect ratio ranging from 5:1 to 1:10, preferably from 3:1 to 1:10, and more preferably from 2:1 to 1:10. In preferred embodiments, the length-to-width ratio of the blunt contact region ranges from 2:1 to 1:2, about 1:1, or about 1:2. In yet other preferred embodiments, the width of the stress-applying feature or stress-applying feature base is greater than the width of the stress-applying feature. In yet other embodiments, the height of the blunt contact region (radially spaced from the outer surface of the expandable structure or scaffold at the attachment point of the stress-applying feature) exceeds the length or width of the blunt contact region, exceeds both the length and width, exceeds the length but less than the width, or is less than the length but greater than the width. In yet another embodiment, the circumferential width is equal to or greater than the axial length of at least some of the stress-inducing features.

[0069] In most cases where the expandable structure is a stent (scaffolding), the base of the stress-applying feature does not extend beyond the edge of the outer surface of a single crown region, a single strut region, or a single link region, but in other cases the base may extend beyond the edge of the scaffold surface and / or span two or more adjacent crowns, struts, and / or links.

[0070] The stress-applying features may be configured to shear, rupture, break, crush, depress, or fragment occlusive material on or within the interior wall of a blood vessel, valve, or body lumen, including both arteries and veins within the heart and peripheral vasculature. The occlusive material may often comprise calcified lesions in the form of calcified plaque that partially or completely occlude, or partially or completely surround, a blood vessel, valve leaflet, or lumen. In a preferred embodiment, the features comprise, or consist of, blunt contact regions configured to shear, rupture, depress, break, crush, or fragment occlusive material on or within the interior wall of a vessel or body lumen when the expandable structure, such as a balloon, stent, sleeve, or the like, is inflated or expanded to its radially expanded, deployed configuration. For example, the blunt contact area may also have a peripheral edge that shears, breaks, fractures, crushes, or otherwise fragments occlusive material, while the surface of the blunt contact area prevents the peripheral edge from unintentionally cutting or otherwise causing substantial injury, such as dissection, to the vessel wall, valve leaflet, or body lumen. In yet another example, the stress-applying feature contact area and peripheral edge are blunt, which dilates, recesses, shears, breaks, fractures, crushes, or otherwise fragments plaque or occlusive material when the blunt contact surface and peripheral edge are pushed or pressed against the vessel wall, hardened plaque, valve annulus, valve leaflet, or body lumen. In this example, the peripheral edge is blunted by beveling the edge, polishing the edge, or coating the edge or feature surface. In yet another example, the stress-applying feature surface, comprising the contact region, peripheral region, base, and feature body, is blunt such that when the blunt surface is pushed or pressed against a vessel wall, hardened plaque, valve annulus, valve leaflet, or body lumen, it indents, shears, breaks, fractures, crushes, or otherwise fragments the plaque or occlusive material.In yet another embodiment, the stress-applying features, including the surface contact region, base, and feature body, are blunt and lack a peripheral edge such that when the blunt surface is pushed or pressed against the vessel wall, hardened plaque, annulus, valve leaflet, or body lumen, it indents, shears, breaks, fractures, crushes, or otherwise fragments the plaque or occlusive material. In yet another embodiment, the stress-applying features on one or more surfaces are blunt, blunt-headed, or otherwise cause little to no injury to the vessel, body lumen, annulus, or valve leaflet when the expandable structure including the features is expanded or deployed radially or axially against the vessel wall, body lumen, or valve annulus / leaflet. In yet another embodiment, the stress-applying feature surfaces have the same degree of bluntness or different degrees of bluntness.

[0071] In a preferred embodiment, the stress-applying feature comprises one or more of applying a force to tissue, resistive tissue, plaque, calcified plaque, and / or fibrous plaque to fracture vascular occlusions, indent vascular tissue and / or occlusions, and / or enlarge a vascular or body lumen.

[0072] In preferred embodiments, the stress-applying features on the contact area may comprise one or more of the following configurations: blunt, atraumatic, blunt, and the feature contact area of ​​the stress-applying features shears, dents, and / or ruptures and / or fractures hardened vascular tissue and / or calcified plaque, enlarging the vascular lumen.

[0073] In another embodiment, the stress-applying feature has a body. In another embodiment, the stress-applying feature comprises a base, the base being separate from the feature body, and the feature and base being attached together.

[0074] In another embodiment, the stress-applying features are formed on a balloon, expandable member, sleeve, cage, or other device. In another embodiment, the stress-applying features are formed on the outer surface of a balloon, expandable member, sleeve, or cage, or on the inner surface of a balloon, expandable member, sleeve, or cage. In one embodiment, the stress-applying features are formed on the inner surface of a balloon, sleeve, cage, or expandable member, and the features are configured to protrude radially outward above the surface of the balloon, sleeve, cage, or expandable member in response to expansion of the balloon, sleeve, cage, or expandable member from a crimped or compact configuration to an expanded configuration. In another embodiment, the stress-applying features are formed on the inner surface of a balloon, sleeve, cage, or expandable member, and the balloon, sleeve, cage, or expandable member is then inverted inside out prior to expansion of the balloon, sleeve, cage, or expandable member from a crimped or compact configuration to an expanded configuration, providing the features on the outer surface of the balloon, sleeve, cage, or expandable member.

[0075] The stress-inducing features may be adhered to the outer balloon surface by one or more layers or "spots" of adhesive polymer having a compliance equal to or less than that of the balloon polymer, as described, for example, with reference to Figures 16E-A-16E-G herein, to maintain flexibility of the expandable balloon during navigation of the balloon catheter in the crimped configuration. The layer of adhesive polymer may be applied by spraying, dipping, painting, or other conventional techniques, typically to a thickness in the range of 1 μm to 50 μm, usually 1 μm to 20 μm. The adhesive spot will typically be applied or dispensed as a small droplet, typically having a volume in the range of 0.1 μl to 1 μl, usually 0.1 μl to 0.5 μl, at the location where the stress-applying feature will be adhered (attached) to the outer surface of the balloon.

[0076] The balloon wall typically consists of, or consists essentially of, a single layer of polymer, copolymer, or polymer hybrid, with a thickness that depends on the fabrication material and intended inflation pressure. For example, nylon will typically require a thicker wall than a balloon formed from a harder material such as PET. Nylon and nylon hybrid balloons will typically have a double-wall thickness in the range of 0.02 to 0.1 mm, usually 0.02 to 0.07 mm, while PET balloons will typically have a double-wall thickness in the range of 0.01 to 0.025 mm, usually 0.01 to 0.015 mm. Typically, the balloon wall thickness will be uniform or substantially uniform over most or all of the balloon surface or the balloon working length surface, which is typically, but not necessarily always, cylindrical. For example, a balloon having a uniform or substantially uniform wall thickness over at least the cylindrical central portion of the balloon surface typically has a uniform average wall thickness when inflated or when the balloon is deflated, with the wall thickness varying by no more than ±20%, more usually no more than ±10%, from the average over the length of the cylindrical surface when the balloon is inflated or when the balloon is deflated.

[0077] Adhesive and other polymer layers formed over the balloon surface will typically have a thickness that is 75% or less of the balloon wall thickness (for a single layer), usually 60% or less, and preferably 50% or less. However, the cumulative thickness of multiple layers may be greater, e.g., 150% or less, usually 120% or less, and preferably 100% or less for two layers.

[0078] The balloon wall will typically consist of, or consist essentially of, a single layer of polymer, copolymer, or polymer blend, without any additional materials, additives, or features that would modify or substantially modify the balloon properties, including balloon compliance, expansive force, or flexibility.

[0079] The balloon wall will typically consist of or consist essentially of a single layer of polymer, copolymer, or polymer blend configured to maximize flexibility for navigating vascular anatomy. In this example, the balloon surface consists of a single layer, free of features or materials that would increase the stiffness of the balloon or balloon surface.

[0080] The stress-inducing features may be arranged on the balloon's outer surface in any one or more of a variety of regular and irregular (random) patterns, and the patterns may be the same or may vary across different regions of the outer surface. Typically, the stress-inducing features are arranged in linear rows aligned with the central balloon axis (referred to herein as "axial rows") that are circumferentially spaced across at least the cylindrical central region of the outer balloon surface, and often across the entire outer balloon surface. In such cases, it will often be advantageous to "axially offset" at least some of the stress-applying features in one axial row relative to those in other axial rows to reduce circumferential overlap of the stress-applying features after the balloon has been folded to provide a thinner entry profile, as described in more detail below. As a result, no two stress-applying features will lie on a common circumference of the balloon when inflated; i.e., each pair of axially adjacent stress-applying features will be centered on a circumferential line (circular ring) that is axially spaced from the circumferential line on which the nearest adjacent stress-applying feature lies. Preferably, depending on the diameter or width of the stress-applying features, the centers of adjacent stress-applying features will be sufficiently axially spaced apart so that the features will have a space or "gap" between them; i.e., the feature centers and / or bases will not overlap axially, thus reducing potential circumferential overlap of the features when the balloon is deflated. Most preferably, no two features on the outer surface of the balloon will overlap axially or circumferentially when the balloon is deflated and folded. Broad, exemplary, and preferred dimension ranges are set forth in Table 1 below. [Table 1]

[0081] Because preferred balloons of the present invention will have limited compliance (stretchability at high inflation pressures), their nominal size, when inflated, will be at most slightly larger than when uninflated, typically necessitating folding or folds of the balloon for delivery onto a deployment catheter. The number of pleats or folds will typically depend on the number of axial rows of stress-applying features on the outer balloon surface. For example, a balloon with three axial rows of stress-applying features will typically be folded to have three pleats or folds, with each row of stress-applying features located between each circumferentially adjacent pair of axial rows of folds. In another embodiment, a balloon with four axial rows of stress-applying features may have four pleats or folds, with each row of stress-applying features located between each circumferentially adjacent pair of folds. In other alternative embodiments, some or all of the axial rows of stress-applying features may be located across the pleats or folds of the balloon when folded prior to inflation.

[0082] Balloons of the present invention will typically be free of stiffening members or other components that would affect the compliance or other properties of the balloon differently in one section of the balloon compared to another section of the balloon. Thus, balloons will typically have uniform compliance and other physical properties, including but not limited to compliance (stretchability) and flexibility (ability to bend, navigate anatomy, and / or fold without breaking), at least across their circumferential centers and typically throughout their entire structure.

[0083] The balloons of the present invention are typically inflated to relatively high pressures to enable the stress application characteristics to rupture calcified plaque, usually at least 2 atm, usually at least 5 atm, more usually at least 8 atm, even more usually at least 12 atm, and often 15 atm or higher.

[0084] While in many embodiments and examples, the stress-applying features of the present invention are intended to be placed and attached directly to the exterior surface of expandable structures such as balloons, stents, and graft structures, in other cases they may be placed on the exterior and / or interior surface of an expandable sleeve or similar support structure that may be placed over a conventional balloon or stent or vascular graft. In still other cases, the stress-applying features of the present invention may be placed directly on an angioplasty balloon as a complement or replacement for the blades / elements of a conventional cutting or slitting balloon. In some cases, a balloon having stress-applying features as described herein may be used to expand a stent or vascular graft, with the balloon and stress-applying features being removed from the stent or vascular graft after expansion.

[0085] A wide variety of stress and force applying features are described and claimed herein, such as blunt, domed, sharp element, and the like, and a wide variety of expandable structures or components or substrates are also described and claimed herein, such as stents, grafts, balloons, sleeves, cages, and the like. The present invention will include each and every individual type of stress or force applying element, individually and in combination, and in combination with each and every expandable structure / component.

[0086] Additionally, in some cases, preferred stressing features of the present invention may be incorporated onto scaffolding components that open and splay radially outward from the outer surface of the stent when the stent is radially expanded, hi other cases, a stent or scaffolding with stressing features may be radially contracted after being radially expanded outward.

[0087] In still other cases, the surface of the stress-applying feature, including the blunt contact region, can be roughened or otherwise modified to improve adhesion to the surface of the vessel or calcified lesion, e.g., have one or more tissue-interface features, i.e., features for securely engaging vessel wall tissue, such as texture, abrasion, friction, barbs, spikes, wedges, microstructured patterns, or the like, on, across, or adjacent the surface before, during, or once occlusive material is fractured to minimize mispositioning or sliding of the expandable structure, such as a balloon, sleeve, cage, or scaffold, at or adjacent the stress-applying feature. In yet another example, the base of the feature may be roughened, etched, grooved, patterned, sandblasted, or micropatterned to improve bonding between the base and the expandable structure surface.

[0088] In still other cases, the stress-applying feature may comprise a sharp element protruding outward from the blunt contact region. The sharp element, e.g., a shaft or other body having a sharp tip or edge, is typically configured to concentrate stress when the blunt contact region is pressed against the surface of the occlusive material and engaged against the occlusive material on the wall of the vessel lumen. The height of the sharp element will be selected to be sufficient to enhance or "core" the rupture of the hardened lesion while reducing or eliminating the risk of injury to the arterial wall, both underlying and distal to the lesion. For example, the blunt surface may extend a first distance above the surface of the balloon or scaffold, and the sharp element protrudes from the surface of the blunt contact region a second distance equal to 0.05 to 0.1 mm of the first distance. Typically, the sharp element will have a height or length of at least 0.01 mm, typically in the range of 0.01 mm to 0.2 mm, and usually in the range of 0.01 mm to 0.1 mm.

[0089] In a first aspect, the present invention provides an endoluminal prosthesis comprising a scaffold and a plurality of stress-applying features coupled to an outer surface of the scaffold. The scaffold is comprised, at least in part, of a non-degradable material and is configured to expand from a crimped configuration to an expanded, deployed configuration. At least some of the stress-applying features comprise blunt contact regions spaced outward from the outer surface, the blunt contact regions configured to disrupt occlusive material within a wall of a vascular lumen when the scaffold is expanded from the crimped configuration to the expanded configuration within the vascular lumen. In other examples, the scaffold may be comprised of a degradable material, such as a degradable polymeric material or a degradable metallic material, or a non-degradable material, such as a non-degradable metal or metal alloy material, configured to expand from the crimped configuration to the expanded, deployed configuration.

[0090] In preferred embodiments, the plaque disruption feature is applied to a non-degradable scaffold structure, hi other embodiments, the plaque disruption feature is applied to a scaffold structure that is degradable within a physiological environment, and the degradable material comprises a degradable polymeric material or a degradable metal or metal alloy material.

[0091] In specific examples, the scaffold or expandable structure may have a tubular geometry, such as a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, a dog-bone shape, other shapes, or the like.

[0092] In specific examples, at least some of the blunt contact regions include a peripheral edge configured to concentrate stress upon engagement against occlusive material on the wall of the vascular lumen when the expandable structure, such as a scaffold, is expanded from a crimped configuration to an expanded configuration within the vascular lumen. Such concentrated stress will shear, break, fracture, crush, or otherwise fragment the occlusive material contacted by the blunt contact region. The peripheral edge may be formed by an intersection between the blunt contact region and a peripheral wall that at least partially surrounds the blunt contact region. The blunt contact region may have various shapes or surfaces, such as flat, rounded, convex, or concave.

[0093] In specific examples, the blunt contact region may be flat, or the blunt contact region may be parallel to the outer surface of the scaffold. Alternatively, the blunt contact region may be angled relative to the outer surface of the expandable structure or scaffold. The peripheral wall may be oriented at an angle in the range of 75° to 105° relative to the blunt contact region. The peripheral edge may extend completely or partially around the blunt contact region and may have a width in the range of 10 μm to 200 μm. In some cases, the peripheral edge may be circular, and the width comprises the diameter.

[0094] In specific examples, at least some of the plurality of stress-applying features comprise one or more plates having a total thickness in the range of 0.1 mm to 1 mm, 0.15 mm to 1 mm, or 0.25 mm to 1 mm, and a width in the range of 0.05 mm to 2 mm or 0.1 mm to 2 mm when attached to the surface of the expandable structure or tubular scaffold. At least some of the plates may be configured as disks, stacked disks, truncated cones, disks stacked with truncated cones, ellipsoidal disks, asymmetric cones, and the like. In other examples, the stress-applying features may comprise one or more spheres, balls, hemispheres, partial spheres, or the like forming various shapes such as "snowman" shapes, or other configurations, or combinations thereof.

[0095] In specific examples, the scaffolding may be formed as a conventional intravascular stent, typically comprising a plurality of struts joined by crowns. The struts and crowns may be formed into circumferential rings, and in some cases, the plurality of struts joined by crowns may be joined into a plurality of successive adjacent circumferential rings joined by axial links, and in other cases, the rings may be joined in a spiral or other pattern.

[0096] In preferred cases, at least some of the stress-applying features may be located at or adjacent to crowns, and optionally, at least some of the crowns carrying stress-applying features may not be joined to adjacent rings. In many cases, each stress-applying feature will be located at or adjacent to a crown.

[0097] In alternative cases, at least some of the stressing features may be located on the struts between the crowns, or on one or more links joining adjacent rings.

[0098] In some cases, at least some of the stress-applying features may be arranged in diametrically opposed pairs, and optionally, the crowns of successive diametrically opposed pairs may be circumferentially offset. Such successive diametrically opposed pairs may be circumferentially offset by an angle between 45° and 90°.

[0099] In alternative cases, at least some of the stress-applying features may be arranged in groups of three, four, or five, which may be separated circumferentially by about 120°, 90°, or 72°, respectively, about a circumference or circle on the surface of the expanded structure or tubular scaffold. In other cases, at least some of the stress-applying features may be arranged in groups of three, four, or five, which may be separated circumferentially by about 120°, 90°, or 72°, respectively, about a circumference or circle on the surface of the expanded structure or tubular scaffold.

[0100] In still other cases, the stress-applying features may be arranged in other regular and / or random patterns. For example, in some patterns, consecutive axially spaced stress-applying features will be circumferentially offset by an angle in the range of 5° to 15°. Alternatively, or in addition, at least some consecutive circumferentially spaced stress-applying features may be axially offset by the same or different angles in the range of 5° to 15°.

[0101] In specific embodiments, scaffolds of the present invention may be formed by patterning a tubular substrate, laser cutting a tubular substrate, rolling a cut substrate, bending wire, by three-dimensional printing, or by other known stent fabrication techniques. The stress-applying features may be pre-formed and attached by gluing, soldering, welding, threaded attachment, riveting, crimping, or the like. For example, the stress-applying features may comprise pre-formed plates that are glued to the scaffold with an adhesive. Alternatively, the stress-applying features may be formed in situ by three-dimensional printing, chemical vapor deposition, electrostatic deposition, molding, or folding of scaffold components. For example, the stress-applying features may comprise tabs that are attached to the scaffold and folded over the outer surface of the scaffold.

[0102] In specific examples, the scaffold may comprise a vascular stent or stent-graft. In other examples, the scaffold may comprise a prosthetic valve, a valvuloplasty device, a sleeve, or the like. In each of such cases, the scaffold may be balloon-expandable or self-expanding.

[0103] In a second aspect, the present invention provides a method for disrupting calcified plaque in a patient's vasculature. A scaffold as in any one of the preceding embodiments is expanded from a crimped configuration to an expanded configuration within a calcified body vessel lumen. A plurality of stress-applying features affixed to an outer surface of the scaffold are caused to indent, expand, open, or disrupt occlusive material on or within the wall of the vessel lumen as the tubular scaffold is expanded from the crimped configuration to the expanded configuration. The occlusive material typically comprises hardened plaque or calcification.

[0104] In specific cases, expanding the scaffold comprises expanding a balloon, expanding the scaffold, or alternatively, allowing the scaffold to self-expand. For example, expanding the scaffold may comprise expanding the prosthetic heart valve within the heart valve annulus, the scaffold providing structural support for the heart valve annulus; for example, expanding the prosthetic heart valve may comprise expanding a balloon to expand the prosthetic heart valve within the heart valve annulus, or may comprise removing the crimped elastic scaffold from radial constraint after positioning within the heart valve annulus.

[0105] In other examples, expanding the scaffolding includes expanding the annuloplasty device within the heart valve annulus. The scaffolding of the annuloplasty device may comprise an expandable cage, and expanding the annuloplasty device includes expanding the cage within the heart valve annulus.

[0106] Cages according to the present invention may be formed from elastic and / or malleable metals, metal alloys, and polymers, including, but not limited to, any of the materials described herein for fabricating scaffolds and stents. Such cages may be self-expanding, balloon-expandable, or the like, and self-expanding cages may be configured to self-expand and / or radially expand upon release from radial constraint in response to mechanical actuation, e.g., by axial shortening. Each of these radial expansion mechanisms is well known and need not be described further.

[0107] In a third aspect, the present invention provides a method for fabricating a vascular scaffold. The tubular scaffold comprises a plurality of struts within a tubular envelope joined by crowns. A plurality of tabs extending outward from the struts, crowns, and / or connectors within the tubular envelope are folded over the outer surface of the tubular envelope to form a plurality of stress-applying features on the outer surface of the tubular scaffold.

[0108] In a specific case, adjacent tabs of a pair that are folded one over the other form stacked stress-applying features. Adjacent tabs within a pair may be arranged side-by-side on the scaffold prior to folding. Alternatively, adjacent tabs within a pair may be arranged in tandem on the scaffold prior to folding. As a further alternative, adjacent tabs within a pair may be arranged on opposite sides of a strut prior to folding.

[0109] Stress-applying features can also be located on extensions to crowns, struts, links, or other structural elements of the scaffold. The extensions can be supported or connected to the same or different structural elements on the same ring or diametrically opposed rings, and preferably the extensions have free terminal ends and the stress-inducing features are located on or centered around such terminal ends. Such extensions can have widths that are the same or different from those of the elements from which they extend and can have any one of a variety of shapes and configurations.

[0110] The stress-inducing features may be located on the struts, strut extensions, crowns, crown extensions, links, and / or link extensions. Preferably, the stress-inducing features are located on the distal or other free ends or side structures of the crowns, struts, links, or extensions that are deflectable in a radially outward direction when the scaffold is expanded from the crimped configuration to the deployed configuration, e.g., are free to deflect as a "cantilevered" element. In further preferred embodiments, the stress-inducing features are located on the distal ends of the extensions or on hinge elements that comprise the crowns or portions of the links, such as Z-, M-, W-, U-, V-, or S-shaped links.

[0111] In some cases, stress-inducing features can be located on the interior surface of the scaffold, for example, on the cantilevered ends of crown regions or extensions, strut regions or extensions, and / or link regions or extensions. In such cases, expansion of a balloon or other expandable element within the scaffold will deflect the cantilevered ends radially outward relative to the remainder of the exterior surface of the scaffold (the features on the interior surface will act as a spacer, preferentially expanding the exterior surface), thus acting as if the features were located on the exterior surface of the scaffold. In such cases, the features on the interior surface need not be configured to rupture occlusive material (preferably configured so as not to damage the expanding balloon), and the exterior surface of the deflected crowns, struts, links, or extensions will have a peripheral edge configured to fragment or crack plaque, calcium, or other occlusive material.

[0112] In some cases, stress-inducing features may be held on the exterior or interior surface of the scaffold by arms, clamps, or other connecting elements that are fabricated along with the scaffold. Such stress-inducing features may be bonded and positioned in place (e.g., by bending an attachment arm), but are not affixed. In such cases, the stress-inducing features may contact the surface of the scaffold, or there may be a gap left between the feature and the surface of the scaffold. As in other cases, these stress-inducing features will contact occlusive material upon expansion of the scaffold.

[0113] In some embodiments, multiple stress-inducing features may be circumferentially and axially offset within a circumferential ring or a single or more than single row of circumferential features of an expanded structure. For example, three stress-inducing features located on three crowns in a ring would be circumferentially offset, but may or may not be axially offset. They would be axially offset if the crowns were axially offset and / or some of the stress-inducing features were located on struts.

[0114] The stress application features of the present invention will typically have a blunt contact area, but as described above, in alternative cases they may comprise a cone or pyramid, which may or may not be untruncated and may or may not comprise a blunt contact area.

[0115] In a further aspect of the invention, an apparatus for treating hardened plaque or calcification on or in a wall or valve annulus or valve leaflet in a body vessel or lumen of a patient comprises: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed at or near the distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward the inner surface of the vessel wall, body lumen wall, or valve annulus; and a plurality of stress-applying features distributed across the outer or inner surface of the expandable structure, at least some of the stress-applying features being attached to the outer or inner surface of the expandable structure and, in one example, having a convex, rounded upper or base surface configured to indent, open, dilate, or rupture calcifications in the vessel or body lumen when the expandable structure is expanded within the vessel or body lumen while minimizing damage to the vessel or body lumen. The expandable structure may be advanced into the target vessel or body lumen prior to advancing a balloon catheter through the expandable structure to expand the expandable structure and fracture the hardened plaque.

[0116] Alternatively, the expandable structure is advanced over a balloon catheter already in position at the target site, and the expandable structure is then bridged (set across) the balloon section prior to inflation of the balloon, expanding the expandable structure and fracturing the hardened plaque. In yet a third embodiment, the expandable structure is bridged (set across) the balloon section of the balloon catheter prior to insertion into the patient's body, and the system is introduced into the patient's body together. In yet a fourth alternative, the expandable structure is advanced distally to the target site, the balloon catheter is advanced to the target site, and the expandable structure is retracted (set across) the expandable balloon section to expand the expandable structure. In one preferred embodiment, the expandable structure comprises an elastic tubular body expandable from a crimped, folded, or other reduced-width configuration to an expanded configuration. In another embodiment, the expandable structure comprises a cage comprising two or more elongate members that separately axially and circumferentially connect the distal end of the catheter to the proximal end of the catheter distal section, the elongate members not connected to adjacent members other than at the proximal and distal ends, and the elongate members are expandable from a small configuration to a larger expanded configuration.

[0117] In another embodiment, a device such as in at least some of the embodiments may be configured to treat a blood vessel, valve annulus, venous valve, or AV shunt, in any of the embodiments, a body lumen, where hardened plaque or calcification is typically located on or within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0118] In some embodiments, the expandable structure may be less rigid when unexpanded and more rigid when fully expanded.

[0119] In some embodiments, the outer surface of the expandable structure may be substantially cylindrical when fully or partially deployed or expanded, hi other embodiments, the expandable structure may be oval, convex, hourglass-shaped, tapered, conical, ellipsoidal, or other shape or configuration when expanded or deployed to the expanded configuration.

[0120] In some embodiments, the stress-applying features comprise convex, rounded upper surfaces of the plurality of stress-applying features that may extend radially outward beyond the outer surface of the expandable structure when fully expanded. For example, the convex, rounded upper surfaces of the plurality of stress-applying features may extend radially outward beyond the outer surface of the expandable structure a distance ranging from 0.25 mm to 3 mm, preferably 0.5 mm to 3 mm, when partially or fully expanded.

[0121] In some examples, the convex, rounded upper surface of the stress-applying features may be free of edges and irregularities that may damage the wall when the expandable structure is expanded within a body lumen.

[0122] In some examples, at least some of the stress-applying features may have a single convex rounded upper surface and a lower base that is independently attached to the outer surface of the expandable structure.

[0123] In some examples, at least some of the stress-applying features may have a convex, rounded tissue-contacting surface (typically an upper surface) and a base (typically a lower base) that is attached to the surface of the expandable structure. The base typically has a lower surface that is flat or otherwise configured to be attached, directly or indirectly, to the outer surface of the balloon by a polymer adhesive.

[0124] In some examples, at least some of the stress-applying features may have a concave tissue-contacting surface and a base attached to a surface of the expandable structure, while in other examples, at least some of the stress-applying features may have a convex tissue-contacting surface and a base attached to a surface of the expandable structure.

[0125] In some examples, at least some of the stress-applying features may have a convex, rounded tissue-contacting surface and a base attached to a surface of the expandable structure, the base having a maximum configuration or dimension of the feature maximum configuration or dimension.

[0126] In some embodiments, at least some of the stress-applying features are formed from a metal or metal alloy. In other embodiments, the features are formed from a polymeric material. In yet a third embodiment, the features are formed from a polymeric material and coated with a harder material, such as a metal or metal alloy material, to provide the necessary hardness to fracture the hardened plaque. In yet another embodiment, the material forming the features may be ceramic. In yet another embodiment, the material forming the features may be coated with a harder material to provide sufficient strength to fracture the hardened plaque. In yet another embodiment, the material forming the features may be coated with a softer (lower hardness) material to provide roundness, convexity, lubricity, frictionlessness, or bluntness, such as in embodiments of metallic materials forming the features and such materials are coated with adhesive materials, polymeric materials, and / or hydrophilic coatings. In yet another embodiment, the material forming the features may be coated with a similar hardness material to provide one or more of a rounded, convex, blunt, and / or atraumatic surface.

[0127] In another example, the plaque disruption features may have the same or different heights, widths, lengths, diameters, shapes, and / or configurations along the circumference and / or axial length of the expandable structure.

[0128] In some embodiments, at least some of the stress-applying features consist of or comprise a secondary surface, configuration, or shape. In some embodiments, the base surface of a post-formed feature attached to the expandable structure surface is flat, oval, rounded, square, rectangular, or contoured relative to the expandable structure surface. In some embodiments, the maximum height from the contact area to the base of the post-formed feature is approximately equal to half the maximum width, length, or diameter of the base of the feature. In other embodiments, the maximum height from the contact area to the base of the post-formed feature is less than half the maximum width, length, or diameter of the base of the feature. In still other embodiments, the maximum height from the contact area to the base of the post-formed feature is greater than half the maximum width, length, or diameter of the base of the feature.

[0129] In some embodiments, at least some of the stress-applying features comprise a secondary shape or configuration comprising at least one of a spherical, ellipsoidal, oblate, or prolate structure.

[0130] In some embodiments, at least some of the stress-applying features consist of or comprise partial spherical, partial ellipsoidal, partial oblate, or partial prolate structures.

[0131] In preferred embodiments, at least some of the metal, hard polymer, ceramic, or other plaque disruption features have contact area surfaces that are formed to have rounded, contoured, blunt, smooth, convex, symmetrical, asymmetrical, concave, regular, irregular, faceted, polyhedral, and / or other surface geometries. Polyhedral facet surfaces may comprise 4 to 100 or more facets, and individual facets may be triangular, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or the like. The exposed surfaces of the plaque disruption features may be irregular, e.g., have grooves, crevices, striations, or the like, over all or a portion thereof. The exposed surfaces of the plaque disruption features may be textured, e.g., sandblasted, to impart desired surface irregularities.

[0132] Optionally, the irregular surfaces of metal, hard polymer, ceramic, or other plaque disruption features may be partially or completely coated, as just described, to partially smooth and / or sufficiently lubricate the surface to facilitate advancement of a balloon or other expandable element bearing these features through the tortuous anatomy of the vasculature or anywhere else.

[0133] In preferred embodiments, at least some of the plaque disruption features have contact area surfaces that are formed to have rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces. In other embodiments, the plaque disruption feature contact area surfaces are coated, covered, or plated with a material to provide the rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces. In one embodiment, the coated, covered, or plated material is a metal, polymer, ceramic, or other type of material configured to provide the rounded, contoured, blunt, smooth, convex, and / or atraumatic surfaces.

[0134] In preferred embodiments, at least some of the plaque disruption features have their entire surface above a base surface that is formed, plated, coated, or covered onto an expandable structure surface that has a rounded, contoured, blunt, smooth, convex, and / or atraumatic surface.

[0135] In preferred embodiments, at least some of the plaque disruption features have their entire surface, including the base surface, attached to the expandable structure surface as formed, plated, coated, and / or covered, being rounded, blunt, smooth, convex, rounded, and / or atraumatic.

[0136] In some examples, at least some of the stress-applying features may comprise a spherical or ellipsoidal shape.

[0137] In other embodiments, at least some of the stress-applying features are formed from spheres, partial spheres, or hemispheres. In one embodiment, the maximum height of the partial spheres ranges from 0.1 mm to 3 mm, preferably from 0.25 mm to 2 mm. In one embodiment, the maximum diameter of the partial spheres ranges from 0.1 mm to 2 mm, preferably from 0.25 mm to 1 mm. In yet another preferred embodiment, the partial spheres have a configuration ranging from 10% to 90% of a spherical configuration, preferably from 25% to 75% of a spherical configuration. In a preferred embodiment, the partial spheres are hemispheres (half of a sphere). In a preferred embodiment, the plaque disruption feature comprises a plurality of spheres, and the sphere diameter ranges from 0.20 mm to 2 mm, preferably from 0.25 mm to 1 mm. In another embodiment, the plaque disruption feature comprises a plurality of partial spheres or hemispheres. In one embodiment, the partial spheres or hemispheres have a maximum diameter ranging from 0.2 mm to 2 mm, preferably from 0.25 mm to 2 mm. In another embodiment, the multiple spheres, partial spheres, or hemispheres have the same size, height, and / or diameter along the expandable structure circumference and / or axial length. In other embodiments, the plaque-fracturing spheres, partial spheres, or hemispheres have different sizes, heights, and / or diameters along the expandable structure circumference and / or axial length. The partial spheres, in one embodiment, may be directly attached to the expandable structure surface. In another embodiment, the partial spheres may have a separate base attached to the expandable structure surface and to the partial sphere base. In yet another embodiment, the partial spheres may have an integral base attached to the expandable structure surface.

[0138] In some examples, at least some of the stress-applying features may comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure, e.g., the lower surfaces may be flat or contoured relative to the expandable structure surface.

[0139] In some embodiments, at least some of the stress-applying features may comprise posts having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0140] In some embodiments, the expandable structure may comprise an inflatable balloon, for example, the inflatable balloon may have a compliance of less than or equal to 10% when inflated to a pressure of at least 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0141] In some embodiments, the stress-applying features are attached to the exterior surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, fusing, heat welding, fasteners, solvent bonding, bonding with a polymeric material, or combinations thereof. In preferred embodiments, the plaque-breaking features are bonded using two or more adhesives, one adhesive that adheres better to or is more compatible with the expandable structure material, while another adhesive that adheres better to or is more compatible with the feature material.

[0142] In some embodiments, the inflatable balloon has a central surface region, a distal tapered surface region, and a proximal tapered surface region, and the stress-applying feature or features are present on one or more of these surface regions. In some embodiments, the inflatable balloon has a central surface region, a distal flat region and / or a proximal flat region, one or more radially protruding surface regions, one or more hourglass regions, and / or one or more oval-shaped regions, and the stress-applying feature or features are present on one or more of these surface regions. Typically, the stress-applying feature or features are present on at least the central region. More typically, the stress-applying feature or features are present radially on or formed as protruding surface regions on at least one of the distal flat or tapered region and / or the proximal flat or tapered region, and sometimes the stress-applying feature or features are present on both the distal and proximal tapered regions. In some cases, the stress-applying features are present on at least a central region, and the central region adjacent the proximal and / or distal tapers of the balloon are voids of stress-applying features. In some cases, the stress-applying features are present on at least a central region, and the central region adjacent the proximal and / or distal tapers of the balloon are voids of stress-applying features, and the region extending in length from 0.1 mm to 3 mm is voids of stress-applying features.

[0143] In some embodiments, the device may further include an outer sleeve having plaque disruption features on an inner or outer surface thereof, the sleeve typically being advanced or retracted in vivo over an expandable structure such as a balloon, the outer sleeve features projecting radially outward prior to or in response to advancing or retracting the sleeve over the balloon or in response to inflation of the balloon to an expanded configuration, the sleeve conforming to the stress application features when the expandable structure is expanded, and the elastomeric tubular member configured to expand and contract with the expandable structure expansion and contraction.

[0144] In another example, the elastomeric tubular member may be placed over an expandable structure, such as a balloon, including plaque-breaking features, and the sleeve shields the stress-applying features as the device is advanced or retracted within a body vessel or lumen. The sleeve may be laminated to or attached to at least a portion of the outer surface of the expandable structure. For example, the elastomeric tubular member may be attached to the expandable balloon section, a section distal to the expandable balloon section, or a section proximal to the balloon section. Alternatively, the outer sleeve may comprise an elastic, non-distensible, or semi-compliant sheath that covers or is folded over the balloon before the balloon is inflated. In most cases, the outer sleeve completely covers the clot-breaking features on the outer surface of the expandable structure and typically comprises a polymer. In some examples, the outer sleeve comprises sufficient perforations to allow at least some of the stress-applying features to protrude radially outward through the perforations when the expandable structure is expanded. In a preferred embodiment, the perforations allow the contact surface area of ​​the stress-applying feature to protrude through the perforations.

[0145] The sleeve may be formed from a non-compliant polymer, a semi-compliant polymer, and / or a shape-memory polymer, preferably with a glass transition temperature below body temperature. Such polymer sleeves can be reinforced with an expandable / retractable metal or metal alloy frame, such as shape-memory or superelastic nitinol, supported by an internal metal or metal alloy frame, such as shape-memory or superelastic nitinol, or a combination thereof. If the metal or metal alloy is not self-expandable, these polymer sleeves with reinforcement can be opened by first expanding the inner balloon to the appropriate diameter. The balloon is then deflated and advanced into the aortic valve. The sleeve can be folded or crimped so that it self-expands within the body once it exceeds its glass transition temperature of at least 30°C. The polymer sleeve with nitinol reinforcement can have any glass transition temperature, as the metal or metal alloy reinforcement causes the sleeve to expand. Polymeric materials include, but are not limited to, high durometer silicones such as polydimethylsiloxane, poly(diphenyl)siloxane, poly(methyl-co-phenyl)siloxane, poly(methyltrifluoropropyl)siloxane, poly(methyl-co-methyltrifluoropropyl)siloxane, or equivalents, polyethylene, polypropylene, polyamide, Pebax, polyurethane, and copolymers thereof such as Bionate, Desmocoll, Texalan, NeuSoft, Tecoflex, Pellethene, Clonoflex, Clonoprene, Clonocene, Clonosil, polymer hybrids, or equivalents, polyethylene vinyl acetate, polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropene, polybutyl methacrylate, poly(styrene-butadiene-styrene), or equivalents.

[0146] For example, at least some of the stressing features or stressing features may be attached to the inner surface of the elastomeric tubular member or the expandable balloon. In certain cases, at least some of the stressing features may be formed as protrusions from the inner surface of the elastomeric tubular member and are forced to protrude radially outward across the elastomeric tubular member or balloon when the expandable structure is advanced or retracted inside the tubular member and / or when the expandable structure is expanded inside the elastomeric tubular member or when the balloon is inflated.

[0147] In some embodiments, the device may further include an outer sleeve or balloon member having a radially outwardly facing protrusion formed from the same material as the sleeve or balloon, where the feature is hollow at its base or includes a hole at its base, and the feature covers, encapsulates, or sits on the outer surface of the sleeve or balloon protrusion. The protrusion provides a larger surface area for attachment to the feature. The protrusion typically has a configuration that will fit within or inside the feature, with the fit ranging from a loose fit to a tight fit. The height of the protrusion ranges from 10% of the feature height to 100% of the feature height.

[0148] In some embodiments, the device may further include an outer sleeve or balloon member having a radially inward-facing protrusion, funnel, or depression formed from the same material as the sleeve or balloon, wherein the feature seats within the outer surface of the sleeve or balloon depression, and the depression partially covers the feature surface, ranging from 10% to 60% or greater than 60% coverage of the feature surface. The depression provides a larger surface area for attachment to and adhesion to the feature when the sleeve or balloon is advanced and / or retracted within the patient's body or when the sleeve and / or balloon is expanded to fracture hardened plaque. The depression typically has a configuration that will partially contain the feature. In some embodiments, the feature fits snugly within the depression. In other embodiments, the feature fits tightly within the depression. In certain other embodiments, the feature or the feature base elongates the depression. In yet other embodiments, the depression has a shape or configuration that is contoured relative to the shape of the feature or the feature base. The depression is typically coupled to or attached to the feature by an interference fit and / or one or more adhesive materials that coat the depression surface and / or the feature surface and / or the feature base surface.

[0149] In a further aspect, a device according to the present invention for treating hardened lesions and / or calcifications on a wall in a patient's body lumen comprises a catheter including a catheter body having a proximal end and a distal section. An expandable structure, typically an inflatable balloon, more typically a non-expandable balloon of the type used in angioplasty and valvuloplasty procedures, is disposed on or near the distal section of the catheter body and has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall, and / or configured to be displaced radially and axially, and / or configured to be displaced axially. One or more, typically multiple, depressions (e.g., cavities, recesses, wells, voids, pockets, sockets, or other concavities) are distributed across at least a portion of the outer surface of the expandable structure, and a plurality of stress-applying features are received, and typically supported and immobilized, within at least one, and more typically within at least some, of the depressions.

[0150] In some cases, the stress-applying features may be present in a number of features per mm across at least a portion of the exterior surface of the expandable structure when the expandable structure is expanded. 2 , often 0.1 to 5 features / mm 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 The distribution density is in the range of

[0151] In some cases, at least some of the stress-applying features have convex rounded apexes that protrude above the outer surface, the convex rounded apexes being configured to fracture calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen.

[0152] In some cases, the convex rounded peaks of the stress-applying features have a radial height above the outer surface of the expandable structure within a range of minimums of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.5 mm, and 0.75 mm to maximums of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm.

[0153] In some cases, at least some of the stress-applying features have upper surfaces flush with the outer surface, optionally secured by adhesive, interference fit, encapsulation, ultrasonic welding, and / or combinations thereof.

[0154] In some cases, at least some of the stress-applying features have upper surfaces that are recessed below the outer surface of the expandable structure.

[0155] In some cases, at least a portion of the exterior surface of the expandable structure and stress-applying features is free of any covering structure.

[0156] In some cases, an encapsulation layer covers at least a portion of the exterior surface of the expandable structure and stress-applying features, preventing the stress-applying features from moving on the exterior surface of the expandable structure in a desired pattern.

[0157] In some cases, the depressions have an average width and / or depth ranging from 0.05 mm to 1.5 mm, preferably from 0.1 mm to 0.5 mm, and more preferably from 0.1 mm to 0.25 mm.

[0158] In some cases, at least some of the indentations in the balloon wall are configured to resist dimensional change as the balloon is inflated. For example, at least some of the indentations in the balloon wall may be configured to resist dimensional change as the balloon is inflated to a nominal diameter. Alternatively, at least some of the indentations in the balloon wall may be configured to resist dimensional change as the balloon is inflated to a maximum rated diameter.

[0159] In some cases, at least some of the depressions in the balloon wall are reinforced.

[0160] In some cases, at least some of the indentations in the balloon wall are configured to narrow the narrowed portion of the indentation as the balloon is inflated to a nominal diameter. For example, at least some of the indentations in the balloon wall are configured to narrow the narrowed portion of the indentation as the balloon is inflated. Alternatively, at least some of the indentations in the balloon wall may be configured to narrow the narrowed portion of the indentation as the balloon is inflated to a maximum rated diameter.

[0161] In some cases, the depressions are staggered or patterned along the length and / or circumference of the balloon.

[0162] In some cases, the balloon has one or more of a cylindrical surface, a conical surface, and an opposing surface, and the stress-applying features are disposed across one, some, or all of these surfaces.

[0163] In some cases, the stress-applying features are stiffer than the outer surface of the expandable structure.

[0164] In some cases, the stress-applying feature comprises at least one of a metal, a polymer, or a ceramic material.

[0165] In some cases, the stress-applying feature may be atraumatic, blunt atraumatic, blunt, smooth, atraumatic or other coating, encapsulation, or other encasement.

[0166] In some cases, the stress-applying features may be roughened by sandblasting or other means to improve fracture, or to improve adhesion, or to improve encapsulation of the material.

[0167] In some cases, the stress-applying feature comprises a magnet or a magnetizable material.

[0168] In some cases, the stress-applying feature comprises one or more of a sphere, a hemisphere, a segment of a sphere, a disk, a cylinder, and a cone.

[0169] In some cases, the stress-applying features have bases and crowns, and the bases of at least some of the stress-applying features are disposed within at least some of the plurality of pre-formed depressions.

[0170] In some cases, at least some of the stress-applying features comprise a core material that is encapsulated within a hardened material.

[0171] In some cases, at least a portion of the base of at least some of the stress-applying features is encapsulated within a hardened material.

[0172] In some cases, at least a portion of the crowns of at least some of the stress-applying features are encapsulated within the hardened material. For example, at least a portion of both the bases and crowns of at least some of the stress-applying features are encapsulated within the hardened material. In other examples, the entire outer surfaces of at least some of the stress-applying features are encapsulated within the hardened material. Typically, the core material comprises at least one of a polymer, a metal, and a ceramic material, and the hardened material comprises at least one of a polymer, a metal, and a ceramic material that has a hardness greater than that of the core material.

[0173] In some cases, the stress-applying features are partially or completely distributed across the surface of at least one section of the inflatable balloon selected from the group of sections selected from a central cylindrical section, a central concave section, a central narrow section, a flat end section, a tapered end section, and a conical end section.

[0174] In some cases, at least one surface of at least one section of the inflatable balloon selected from the group of sections selected from a central cylindrical section, a central concave section, a central narrow section, a flat end section, a tapered end section, and a conical end section is free of stress-applying features distributed therethrough.

[0175] In some cases, the inflatable balloon comprises a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to expand over opposing surfaces of the leaflets of a calcified valve to fracture the calcification on the calcified valve.

[0176] The individual stress-applying features may be supported, immobilized, or otherwise received within at least some of the individual depressions after the expandable structure is fully expanded to its maximum expanded configuration.

[0177] The respective stress-applying features may be at least partially supported, immobilized, or otherwise received within the respective depressions after expanding the expandable structure to the expanded configuration.

[0178] The individual stress-applying features may be supported, immobilized, or otherwise received within the individual depressions or at the sites where such depressions previously existed after the expandable structure is expanded to the expanded configuration, and may be secured or attached to the outer surface of the expandable structure by adhesive bonding, fusion, or other attachment means.

[0179] While one or both of the opposing inner wall surfaces of a valvuloplasty balloon or other inflatable or expandable compartmentalized structure of the present invention will typically include a stress-applying feature, as described above, in some cases one or both of the opposing inner wall surfaces may be absent a stress-applying feature. In such cases, the capture and optional compression of a calcified valve leaflet between the opposing inner walls may be sufficient to rupture the calcification on the valve leaflet, even without the presence of a stress-applying feature.

[0180] In some cases, the valvuloplasty catheter may include a non-expandable, segmented structure disposed at the distal end of the catheter body. Such a non-expandable, segmented structure will typically have opposing inner walls configured to be pulled together onto opposing surfaces of the leaflets of a calcified valve to fracture the calcification on the calcified valve. The segmented structure may comprise a solid body, a rigid hollow shell, or the like. Either of the opposing inner wall surfaces may include stress-applying features, as described above with respect to the expandable structure, although in some cases, one or both of the opposing surfaces will be free of stress-applying features. These segmented, non-expandable structures may be formed from polymeric, metallic, ceramic, or other materials, or a combination thereof.

[0181] In yet a further aspect, an apparatus for treating calcification on a wall in a body lumen of a patient according to the present invention comprises a catheter including a catheter body having a proximal end and a distal section. An expandable structure is disposed in the distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall. A plurality of stress-applying features are distributed across the outer surface of the expandable structure, and an energy source internal to the expandable structure is configured to deliver energy to or through the plaque-disrupting features to enhance plaque disruption.

[0182] The stress-applying features of the present invention may be combined with or incorporated into the balloon structures of known cavitation-induced "lithotripsy" catheters, such as those described in PCT Publication Nos. WO2013 / 070750, WO2015 / 017499, WO2018 / 194752, WO2021 / 061451, WO2020 / 256949, WO2021 / 18367, and WO2022 / 216488 (the entire disclosures of which are incorporated herein by reference). In particular, the outer balloon or other expandable member surface of such lithotripsy catheters may incorporate any of the stress-applying features described herein, which features will improve the calcification spalling performance of the catheter.

[0183] In yet another aspect, an apparatus for treating hardened plaque or calcification on a wall in a body lumen of a patient according to the present invention comprises a catheter including a catheter body having a proximal end and a distal section. An expandable structure is disposed in the distal section of the catheter and has an outer surface configured to be displaced radially outward and / or axially toward the inner surface of the body lumen wall. One or more stress-applying features are distributed across the outer surface of the expandable structure, at least some of the stress-applying features being stiffer than the outer surface of the expandable structure.

[0184] In some cases, the stress-applying feature comprises at least one of a metal, a polymer, or a ceramic material.

[0185] In some cases, the stress-applying features are atraumatic, coated, blunt, or blunt.

[0186] In some cases, all or a portion of the stress-applying features may be roughened by sandblasting or other means to improve fracture, or to improve adhesion, or to improve encapsulation of the material.

[0187] In some cases, the stress-applying feature may comprise a magnet or a magnetizable material.

[0188] In some cases, the stress-applying features may comprise a spherical shape, a hemispherical shape, a segment of a sphere, a disk shape, a cylinder shape, and a cone shape.

[0189] In some cases, the stress-applying feature may comprise a core that is covered by a hardened shell.

[0190] Individual or groups of stress-applying features may be mounted on protrusions molded or otherwise formed into the outer surface of the balloon, and typically rendered immobile, after the expandable structure is fully expanded to its maximum expanded configuration.

[0191] Individual or groups of stress-applying features may be mounted, at least in part, on protrusions molded or otherwise formed into the outer surface of the balloon after the expandable structure is expanded to the expanded configuration, and typically are immobilized.

[0192] Individual or groups of stress-applying features may be mounted on the outer surface of the expandable structure (e.g., secured on protrusions) by adhesive bonding, fusing, or other attachment means, or may be molded thereon or otherwise secured or attached thereto, or may be otherwise formed into the outer surface of the balloon after the expandable structure has been expanded to the expanded configuration.

[0193] In an additional aspect, an apparatus for treating calcification on a wall in a body lumen of a patient according to the present invention includes a catheter including a catheter body having a proximal end and a distal section, a balloon having a plurality of preformed indentations formed over at least a portion of an outer surface thereof, the balloon being mounted on or relative to the distal section of the catheter, the bases of multiple stress-applying features being disposed within at least some of the preformed indentations, and the crowns of at least some of the stress-applying features being exposed above the outer surface of the balloon, above the balloon, or beneath the balloon when the balloon is at least partially expanded or when the balloon is fully expanded.

[0194] In some cases, at least some of the stress-applying features comprise a core material that is encapsulated within a hardened material.

[0195] In some cases, at least a portion of the base of at least some of the stress-applying features is encapsulated within a hardened material.

[0196] In some cases, at least a portion of the crowns of at least some of the stress-applying features are encapsulated within the hardened material.

[0197] In some cases, at least a portion of both the base and crown of at least some of the stress-applying features are encapsulated within a hardened material.

[0198] In some cases, the entire outer surface of at least some of the stress-applying features is encapsulated within a hardened material.

[0199] In some cases, the core material comprises at least one of a polymeric material and a ceramic material, and the hardened material comprises at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than that of the core material.

[0200] In some embodiments, at least some of the stress-applying features may have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), where the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, usually 1:1 to 1:5, and more usually 1:1 to 3:1. For example, at least some of the bases may have a circular or oval perimeter. In other embodiments, Wa:Wc is in the range of 3:1 to 1:3, usually ranging from 2:1 to 1:2, more usually 1.5:1 to 1:1.5, and most usually about 1:1. In some embodiments, the base is an integral part attached to the stress-applying features and is attached to the expandable structure surface. In other embodiments, the base is a separate piece from the plaque disruption features and is attached to the plaque disruption features and to the expandable structure surface.

[0201] In some embodiments, at least some of the stress-applying features may be arranged in diametrically opposed pairs. For example, the stress-applying features of successive diametrically opposed pairs may be circumferentially offset. For example, the stress-applying features of successive diametrically opposed pairs may be circumferentially offset by an angle between 45° and 90°.

[0202] In some embodiments, at least some of the stress-applying features may have bases attached to the outer surface of the expandable structure, and the bases of each feature in a group of features centered around the expandable structure circumference do not overlap one another in the expanded configuration. In other embodiments, the bases of each feature do not overlap with the bases of other features located along an axial length of the expandable structure or along the length of the expandable structure axial length. In yet other embodiments, the bases of each feature do not overlap with the bases of other features along the circumference of the expandable structure when expanded, and do not overlap with axially adjacent features along the axial length of the expandable structure when the structure is expanded.

[0203] In some embodiments, at least some of the stress-applying features may be arranged in groups of three, which are circumferentially separated by approximately 120° around a circle on the surface of the expandable structure.

[0204] In some embodiments, at least some of the stress-applying features may be arranged in two groups, which are circumferentially separated by approximately 180° around a circle on the surface of the expandable structure.

[0205] In some embodiments, at least some of the stress-applying features may be arranged in groups of four, which are circumferentially separated by approximately 90° around a circle on the surface of the expandable structure.

[0206] In some embodiments, at least some of the stress-applying features may be arranged in two to four groups, each separated circumferentially by approximately 90° to 180° around a circle on the surface of the expandable structure, with each group forming a helical pattern along the length of the expandable structure when the structure is in the expanded configuration.

[0207] In some examples, at least some of the stress-applying features may be arranged in groups of 3 to 10 features per group, separated circumferentially by approximately 36° to 120° about a circle on the surface of the expandable structure, and each feature footprint or base about the circle does not overlap more than one other feature footprint or base along the circle.

[0208] In some embodiments, at least some of the stress-applying features may be arranged in groups of 3 to 10 features per group, separated circumferentially by approximately 36° to 120° about a circle on the surface of the expandable structure, each feature footprint or base about the circle overlapping no more than two other feature footprints or bases along the circle, and each feature about the circle overlapping no more than 1 to 5 other features along the axial long path of the expandable structure when the structure is expanded, preferably along the entire length of the expanded structure.

[0209] In some examples, at least some of the stress-applying features may be arranged in groups of 3 to 10 features per group, separated circumferentially by approximately 36° to 120° about a circle on the surface of the expandable structure, such that each feature footprint or base from each group about the circle does not overlap with other feature footprints or bases from the same group along the circle, and such that each feature about the circle also does not overlap with other features from other groups along the axial length of the expandable structure when the structure is expanded, preferably along the entire length of the expanded structure.

[0210] In some embodiments, at least some of the stress-applying features may be arranged in groups of 3 to 10 features per group, separated circumferentially by approximately 36° to 120° about a circle on the surface of the expandable structure, such that each feature footprint or base from each group about the circle has a gap when the underlying structure is fully expanded between that feature and other feature footprints or bases in the same group, the gap ranging from 0.05 mm to 2.5 mm, preferably 0.1 mm to 1.5 mm. In preferred embodiments, the gap between any two features in the same group is measured along the axial length between the two feature footprint or base circles.

[0211] In some embodiments, at least some of the stress-applying features may be arranged in groups of 3 to 10 features per group, randomly separated circumferentially by approximately 10° to 180° about a circle on the surface of the expanded structure.

[0212] In some embodiments, the stress-applying features may be arranged in a helical pattern along the length of the expandable structure, preferably along the entire length of the expandable structure, when the structure is in the expanded configuration. In some cases, the helical pattern of at least some of the stress-applying features completes one to five 360° turns along the length or along the entire length of the expanded structure. In some embodiments, the plaque disruption features or feature bases do not overlap around the circumference and / or axial length of the expandable structure.

[0213] In some examples, the stress-applying features may be arranged in a linear pattern along the length of the expandable structure, preferably along the entire length of the expandable structure, when the structure is in the expanded configuration.

[0214] In some examples, the stress-applying features may be arranged within one region of the expandable structure, for example, the plaque-rupturing features may be arranged within a central region of the expandable structure, such as a cylindrical or other working length of a structure such as an inflatable balloon.

[0215] In other examples, an inflatable balloon coupled to a plaque disruption feature may be arranged to prevent an outer surface of the expandable structure, such as the balloon outer surface, from contacting hardened plaque or tissue, or to have the outer surface of the balloon not contact hardened plaque prior to a minimum threshold pressure, which may be any one of the following nominal or rated balloon inflation pressures: 3 atm, 5 atm, 7 atm, 10 atm, 12 atm, 15 atm, or others.

[0216] In other embodiments of the present invention, an expandable structure, such as an inflatable balloon, may be further configured to deliver drugs and other agents. For example, the inflatable balloon may be configured to release an inflation medium comprising a drug in response to an inflation pressure above a minimum threshold, e.g., above 1 atm, 3 atm, 5 atm, or 7 atm. In specific cases, the inflatable balloon may include multiple ports or perforations in the balloon material surface adjacent to at least some of the features, which open in response to an inflation pressure above a minimum threshold pressure. In certain other embodiments, the inflatable balloon may have a separate distal conduit formed from the elongated tubular body extending proximally from the distal conduit to the outside of the patient, and may infuse drugs while the balloon is in the expanded configuration. In yet another embodiment, a drug is coated on the stress-applying feature surfaces, more specifically, on one or more of the engagement or contact surface areas of the stress-applying features, to provide the drug to the tissue when the features contact vascular, annular, or leaflet tissue. In one example, the drug is coated or sprayed directly onto at least the contact area surfaces of at least some of the features. In another example, the drug is mixed with a polymer material, and the mixture is then coated or sprayed onto at least the contact area of ​​the stress-applying features. In yet another example, the drug is sprayed or coated onto the outer surface of an expandable structure outer surface, such as a balloon and / or stress-inducing features. In yet another example, the expandable structure comprises an expandable balloon section, the balloon section covered by an outer sleeve comprising an elastomeric member, the balloon and / or elastomeric member comprising at least some stress-applying features attached to the outer surface of the balloon, the outer surface of the elastomeric member, and / or the inner surface of the elastomeric member, the outer surface of the elastomeric member being coated with a drug comprising one or more drugs. The drug coating at least some of the features embeds in the vessel wall, body lumen, or valve annulus upon balloon inflation, embedding at least a portion of its drug content in adjacent tissue.In a preferred embodiment, the drug comprises one or more of an antiproliferative drug, an mTOR inhibitor drug, a taxol or analog drug, a direct thrombosis inhibitor drug, and a factor Xa inhibitor drug. In yet another embodiment, the drug is located within the space between the outer surface of the balloon compartment and the inner surface of the elastomeric compartment and is allowed to permeate the elastomeric member through openings or perforations in the elastomeric member upon balloon expansion and release the drug into the vessel wall, body lumen, or valve annulus.

[0217] In certain embodiments, the expandable structure comprises a balloon having an outer surface. The outer surface typically comprises a plurality of stress-applying features, as described elsewhere herein. The outer surface of the balloon and / or the stress-applying features are coated with one or more drug formulations, including antiproliferative agents, anticoagulants, and antiplatelet agents. Examples of anticoagulants include direct factor Xa inhibitors, direct factor IIa inhibitors, and the like. Examples of antiproliferative agents include rapamycin, rapamycin analogs and derivatives, taxol, and taxol analogs and derivatives. The formulation of the one or more drugs may further comprise or include one or more excipients, one or more plasticizers, one or more contrast agents (such as iopromide), one or more polymeric materials such as PLLA or PLGA, or PCL, acetyl tributyl citrate, one or more cationic surfactants such as urea, polyethyleneimine, butyryl trihexyl citrate, UV curable materials such as PVP hydrogels, non-ionic surfactants such as polysorbate / sorbitol, amphiphilic polymers such as PEG; encapsulated drugs such as encapsulated nanoparticle drugs, micelle encapsulated drugs, and phospholipid encapsulated drugs, PLGA microspheres, and combinations thereof.

[0218] In yet another aspect, the invention provides a method for treating calcifications on a wall in a body lumen of a patient, the method including positioning an expandable structure at a treatment site proximate the calcification to be treated and expanding the expandable structure radially outward to press a plurality of stress-applying features radially outward against the calcification, the stress-applying features being distributed across an outer surface of the expandable structure, at least some of the stress-applying features being independently attached to the outer surface of the expandable structure and having a convex, rounded upper surface, and pressing the plurality of stress-applying features radially outward against the calcification disrupts the calcification while reducing damage to the wall.

[0219] In yet another aspect, the present invention provides a method for treating calcification on a valve of a patient having calcified leaflets, the method including positioning an expandable structure at a treatment site proximate the calcification to be treated (such as within or through the calcified leaflet) and expanding the expandable structure radially outward such that the stress-applying features press the calcified leaflet against the wall of the annulus and rupture the calcified leaflet. The stress-applying features are distributed across an outer surface of the expandable structure, at least some of the stress-applying features being independently attached to the outer surface of the expandable structure and having a convex, rounded upper surface.

[0220] In yet another aspect of the present invention, a device for treating a valve in a patient with calcified valve leaflets includes a catheter body and a segmented balloon structure. The catheter body has a proximal end and a distal end. The segmented balloon is disposed at the distal end of the catheter body and has opposing inner walls (sidewalls) configured to be expanded over opposing surfaces of the calcified valve leaflets in a manner to fracture the calcifications on the leaflets. In one embodiment, the inner sidewalls (or axially facing walls) of the segmented balloon are flat or protrude axially outward when the balloon is expanded and presses against the calcified leaflet surfaces from opposite sides, fractures the calcifications on the calcified valve. In yet another embodiment, at least one of the segmented balloon inner sidewalls includes one or more stress-applying features coupled to the sidewall and configured to engage the calcified valve leaflets when the balloon is expanded and fractures the calcifications, the features pressing the calcifications against the opposing inner sidewall of the segmented balloon. In yet another embodiment, the compartmentalized balloon inner sidewall comprises one or more stress-applying features coupled to the wall and configured to engage the calcified leaflets from opposite sides when the balloon is expanded to fracture the calcification. In yet another embodiment, the number of stress-applying features is between 0.1 and 100 features / mm. 2 and preferably between 0.1 and 30 features / mm of the interior sidewall surface. 2 and more preferably 1-20 features / mm of the interior sidewall surface. 2In yet another embodiment, the stress-applying features may be arranged across the side surface of the expandable structure in various configurations, such as a circular pattern, a circle within a circular pattern, a spiral pattern, a leaflet-conforming or contoured pattern, or other patterns. In another embodiment, at least some of the stress-applying features on one side of the compartmentalized balloon inner wall are configured (or arranged) to face other stress-applying features on the opposing inner wall. In another embodiment, at least some of the stress-applying features have blunt contact areas on one side of the compartmentalized balloon inner wall configured (or arranged) to face other stress-applying feature blunt contact areas on the opposing inner wall when the balloon is expanded to fracture calcifications between the opposing blunt contact areas. In another embodiment, at least some of the stress-applying feature contact areas configured to have a convex shape on one side of the compartmentalized balloon inner wall are configured (or arranged) to face other stress-applying feature contact areas on the opposing inner wall configured to have a concave shape for fitting into the convex oppositely shaped feature when the balloon is expanded to fracture calcifications between the opposing blunt contact areas.

[0221] In yet another embodiment, at least some of the features on one side of the inner wall are configured to invaginate, or at least partially invaginate, spaces between two, three, four, or more than four features on the opposing inner sidewall of the compartmentalized balloon when the balloon is inflated to fracture calcifications within the valve leaflets. In another embodiment, the sidewall and / or inner wall may be covered by an elastomeric member that covers at least some of the features, optionally attached to the balloon compartment or other compartment of the balloon catheter and configured to expand when the balloon is expanded.

[0222] In another embodiment, the inner sidewall and / or elastomeric member are configured to expand radially and / or axially when the balloon is inflated (or fully expanded) and presses against the calcified leaflets, crushing the calcification therein. In an alternative embodiment, sections of the balloon structure are slidably attached to or mounted on the shaft of the catheter and configured to draw the inner sidewalls together after inflation, optionally configured to nest when the balloon structure is expanded, typically having nesting conical surfaces.

[0223] In yet other embodiments, the opposing inner walls may comprise flat surfaces configured to converge toward one another when the balloon structure is inflated and / or expanded. For example, the compartmentalized balloon structure may comprise a pair of opposing conical balloons having flat bases with flat surfaces.

[0224] In some examples, the calcification spalling features on opposing inner wall surfaces are axially aligned as the balloon segments are pulled together, which applies a force to opposing surfaces of the valve leaflets. In other cases, the calcification spalling features on opposing surfaces are laterally offset so that they are not axially aligned as the balloon segments are pulled together. In still other cases, the calcification spalling features may be on only one of the two opposing inner wall surfaces.

[0225] In yet another example, at least one region of the inner compartmentalized balloon sidewall and / or at least some of the regions and / or features of the elastomeric member cover are coated with one or more coatings comprising a polymeric material, an adhesive material, an antiproliferative agent, a factor Xa inhibitor agent, and a factor IIa inhibitor agent, wherein the coating material is configured to deliver a drug, affix fractured calcium debris to the leaflets or the inner wall of the compartmentalized balloon, or repair a perforated leaflet. In another example, the coated material is configured to attach to the leaflet, transfer a material or drug to the leaflet surface, adhere to the leaflet surface, repair a perforation in the leaflet surface, or hold the leaflets together.

[0226] In another example, at least some of the features on opposing sides of the interior sidewall of a compartmentalized balloon fit within one another, such as concave and convex contact surface areas, ball and socket contact surface areas, or the like. In some examples, the calcium fracturing features on an expandable structure, such as an expandable balloon, may be arranged on one or more of the expandable structure surfaces, including a side surface, an interior surface, or an axially facing surface. In some examples, the expandable structure, such as an expandable balloon, comprises one or more shapes, including a tubular shape, a donut shape, an hourglass shape, a tapered shape, an oval shape, a rectangular shape, a square shape, or the like. In yet another example, the axially facing region of the expandable structure may have a variety of shapes, including one or more of flat, convex, concave, donut, or the like.

[0227] In another embodiment of the present invention, a device for treating a valve in a patient having calcified valve leaflets comprises a catheter body having at least two expandable structures, the at least two expandable structures being configured to be expanded together, such as in one embodiment a dual balloon configuration, the dual balloons sharing the same inflation lumen and the same guidewire lumen. In another embodiment, the at least two expandable structures are configured to be expanded independently, such as at least two balloon structures having separate inflation lumens and the same or separate guidewire lumens for the at least two balloon structures. In a preferred embodiment, the dual expandable structures are axially movable over a common axial tubular structure.

[0228] In a specific example, the valve calcification treatment device will further comprise a plurality of calcification-breaking features distributed across at least one of the opposing interior walls of the compartmentalized balloon structure, preferably across both opposing interior walls (and / or the axially facing walls). The calcification-breaking features may comprise any of the stress-applying and calcification-breaking features described herein, typically comprising rounded features, including those hemispherical, ball, and spherical features, as described herein.

[0229] Preferred fracturing features will typically have convex, rounded leaflet-engaging surfaces configured to fracture calcifications while minimizing damage to the leaflets when the balloon structure is expanded within a patient's valve. Typically, the convex, rounded upper surfaces of the stress-applying features will be configured to extend from the opposing inner wall to engage the leaflets when they are trapped between the walls. The leaflet-engaging rounded surfaces of the features will typically have a height or width within the range of 0.01 mm to 3 mm, 0.1 mm to 3 mm, and usually 0.5 mm to 2 mm when the balloon is fully inflated. In most cases, the convex, rounded upper surfaces of the calcification fracturing features will be free of edges and irregularities that could damage the leaflets when the balloon structure is expanded within a patient's valve.

[0230] However, in some cases, the calcification-breaking features may include sharp elements protruding outward from the convex, rounded upper surface, configured to concentrate stress when engaged against calcifications on the leaflets as the balloon surface presses against the leaflet surface. The sharp elements may have very minimal height or depth so that they will engage and break up calcifications while substantially avoiding any injury to the leaflets. Individual balloon segments may be fixed to the catheter body such that, upon inflation of the balloon structure, they engage and capture the leaflets without any further manipulation. However, in other cases, the balloon segments may be configured to translate axially relative to each other on the catheter body, providing variable spacing between the inner walls. In such cases, a first of the segments may be inflated and engaged against the leaflet and an inflated second segment may then be pulled against the opposing surface of the leaflet to effect fragmentation.

[0231] In yet another aspect, the present invention provides a method for fracturing calcification or plaque in a lesion, comprising advancing a sleeve over a wire through the lesion, advancing an expandable member over the wire into an interior of the sleeve, and expanding the expandable member within the sleeve to radially displace features on the interior and / or exterior of the sleeve outward relative to the lesion to fracturate the calcification or plaque.

[0232] In some examples, the method further includes removing the expandable member from the sleeve and removing the expandable member and sleeve over the wire, where the expandable structure may comprise either a balloon or other expandable member or one of a stent, and the sleeve is left in place between the stent and the lesion after the stent is expanded. The stress-applying features may protrude radially outward from the sleeve into the vessel wall when the expandable structure displaces them radially outward in response to expansion.

[0233] In yet a further aspect, the present invention provides a method for fracturing calcification or plaque in a lesion, comprising advancing a cage or basket over a wire across the lesion, and expanding the cage of the basket to radially displace stress-applying features on the cage or basket relative to the lesion, fracturing the calcification or plaque.

[0234] In some embodiments, expanding the cage or basket includes mechanically reorienting structural components of the cage or basket, hi other embodiments, expanding the cage or basket includes inflating a balloon within the cage or basket, which may be advanced to the lesion with or after the cage or basket.

[0235] In yet another aspect of the invention, an apparatus for treating calcifications on a wall within a body lumen of a patient includes a catheter including a catheter body having a proximal end and a distal segment. An expandable structure is disposed in the distal segment of the catheter body and has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall. A plurality of stress-applying features are distributed across at least a portion of the outer surface of the expandable structure, at least some of the stress-applying features being disposed on the outer surface of the expandable structure and having convex, rounded apexes configured to fracture the calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen.

[0236] In particular cases, the convex rounded apexes of at least some of the stress-applying features have a radial height above the outer surface of the expandable structure within a range of a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm when the expandable structure is expanded, and a radial height above the outer surface of the expandable structure within a range of 0.1 to 5 features / mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2and a distribution density within the range of

[0237] In other specific cases, the stress-applying feature may have a footprint with a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0238] The stress-applying features may have any one or combination of properties including, for example, any one or more of ball, spherical, hemispherical, partial spherical, dome, and ellipsoidal geometries, being solid, being hollow, being coated, being uncoated, having a textured surface, having a smooth surface, being a discrete body, and being comprised of a metal, a polymer, or a combination thereof.

[0239] In preferred aspects, the encapsulation layer may cover some or all of the outer surface of the expandable structure and / or stress-applying features, preventing the stress-applying features from moving in a desired pattern on the outer surface of the expandable structure.

[0240] In particular embodiments, the stress-applying feature may be secured only by the encapsulation layer, or may be secured by the encapsulation layer plus an adhesive between the feature and the exterior surface. The encapsulation layer may encapsulate the entire stress-applying feature, including the rounded apex of the convex surface, or the encapsulation layer may encapsulate only the lower portion of the stress-applying feature, excluding the rounded apex of the convex surface.

[0241] In preferred embodiments, the stress-applying features may be supported within depressions, cavities, recesses, receptacles, or other recesses in the outer surface of the expandable structure, such support helping to anchor and stabilize the stress-applying features during deployment and use.

[0242] The encapsulation layer may comprise one or more polymers selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA), and the like.

[0243] The encapsulation layer is applied over the exterior surface and stress-applying features by any one of coating, direct fluid application, lamination, and fusing.

[0244] The encapsulation layer may have a thickness in the range of 0.01 mm to 0.1 mm (0.5 mils to 5 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0245] The stress-applying features may be constrained across the exterior surface of the expandable structure by an elastic sleeve.

[0246] The stressing features are typically attached to the outer surface of the expandable structure, but in some cases may be attached to the inner surface of the elastic sleeve, hi some cases, the stressing features are mounted on posts that are hollow and project radially outward from the outer surface of the expandable structure.

[0247] In another aspect, a device for treating calcifications on a wall in a patient's body lumen according to the present invention comprises a catheter including a catheter body having a proximal end and a distal section. An expandable structure is disposed in the distal section of the catheter body and has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall. A plurality of stress-applying features are distributed across the outer surface of the expandable structure, at least some of the stress-applying features being present on the outer surface of the expandable structure and having an upper surface configured to fracture the calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen. An encapsulation layer covers the outer surface of the expandable structure and at least a portion of the stress-applying features, and prevents the stress-applying features from moving on the outer surface of the expandable structure in a desired pattern.

[0248] In some cases, at least some of the upper surfaces of the stress-applying features may comprise convex, rounded apexes, and the encapsulation layer may cover the entire exterior surfaces of at least some of the stress-applying features, including the upper surfaces. Alternatively, the encapsulation layer may cover only lower portions of the exterior surfaces of at least some of the stress-applying features. Often, the stress-applying features will be disposed within depressions, recesses, receptacles, or other indentations on the exterior surface of the expandable structure. Alternatively, the stress-applying features may comprise hemispheres with flat bottoms bonded to the exterior surface of the expandable structure.

[0249] In yet another aspect, the invention provides a method for treating a lesion on a wall within a patient's body lumen comprising providing a catheter having an expandable structure disposed at a distal end thereof, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall, the outer wall having a plurality of spatially separated "spacer" features distributed across the outer surface of the expandable structure, the expandable structure being expanded within the patient's body lumen such that a radially outward force is applied against the wall by the outer surface and the features, while the features maintain a gap between the outer surface of the expandable structure and the inner wall.

[0250] Spacer features are typically configured to create and / or maintain one or more gaps by separating the lesion from the outer surface of the expandable structure adjacent the feature when the structure is in the expanded configuration. Spacer features typically comprise multiple features positioned in a configuration around the circumferential and / or axial length of the expandable structure that provide, create, or maintain the gaps.

[0251] In one case, the spacer features have axially aligned through-holes that allow the passage of fluids such as contrast agents, blood, and / or drug (medicine) solutions therethrough. Typically, the gaps allow fluid perfusion through and beyond the expandable structure as it is expanded. For example, a drug may be perfused into the gaps while the expandable structure is expanded, e.g., the expandable structure comprises a balloon and the drug is perfused through the walls of the balloon. In an alternative case, at least some of the spatial separation features comprise a drug, which is released into the gaps.

[0252] In certain cases, expanding the expandable structure creates one or more gaps between the outer surface and inner wall of the expandable structure under physiological pressure, allowing fluid perfusion through the one or more gaps.

[0253] In preferred cases, the spacer features may comprise convex rounded apexes for the stress application and plaque disruption features of the present invention, as described above.

[0254] The spacer features, when the expandable structure is expanded, have a radial height above the outer surface of the expandable structure ranging from a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and a number of features between 0.1 and 5 per mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density in the range of

[0255] In such perfusion methods, the expandable structure is expanded with a force sufficient to create and / or maintain one or more gaps relative to physiological pressure, typically between 0.5 psi and 5 psi, preferably between 1 psi and 3 psi.

[0256] In yet another aspect, the present invention provides a method for affixing stress-applying features to the outer surface of a balloon, such as an angioplasty balloon, valvuloplasty balloon, or the like. The method includes providing a balloon having an outer surface and, optionally, forming a plurality of indentations over at least a portion of the outer surface of the balloon. Optionally, at least a cylindrical or other working length of the outer surface of the balloon and / or the sides of the balloon are coated with a base layer of elastic polymer. An elastic adhesive is dispensed over the base layer on the outer surface of the balloon or into each indentation, and stress-applying features are placed on the elastic adhesive dispensed on the outer surface of the balloon or into each indentation, displacing a portion of the elastic adhesive onto the outer surface of the balloon surrounding each plaque disruption feature. Each stress-applying feature is optionally coated with a spot layer of elastic adhesive, which forms a seal with the elastic adhesive displaced onto the outer surface of the balloon surrounding each plaque disruption feature. Optionally, a cover layer of elastic polymer is then formed over at least the working length of the outer surface of the balloon and / or the sides of the balloon. Typically, one or more of an elastic polymer, an elastic adhesive, a plaque disruption feature, a spot adhesive, and a cover layer are coated, dispensed, or placed on the balloon after it is expanded to the expanded configuration.

[0257] In some preferred embodiments, at least one of the base layer and the cover layer will be formed as part of the fabrication method, while in other preferred embodiments, both the base layer and the cover layer will be formed as part of the fabrication method.

[0258] In a specific aspect, coating the exterior surface of the balloon with a base layer of elastic polymer comprises coating the exterior surface with a curable elastic adhesive and curing the elastic adhesive.

[0259] In a specific aspect, the elastic adhesive dispensed onto the exterior surface of the balloon and / or within the recesses comprises a light-curable acrylic adhesive.

[0260] In a specific aspect, the spot layer comprises a light-curable acrylic adhesive. Typically, the elastic adhesive dispensed on the outer surface of the balloon or in the depressions and spot layer comprises a chemically similar light-curable acrylic adhesive, and the two adhesives fuse together when cured.

[0261] In yet a further aspect, the present invention provides a device for treating a patient's valve having calcified valve leaflets, the device comprising: a catheter body having a proximal end and a distal end; and a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to be deployed on opposing surfaces of the valve leaflets and to fracture calcification on the calcified valve. Features on one or both of the opposing inner walls are configured to fracture calcified plaque on the valve leaflets as the opposing inner walls are deployed.

[0262] In some cases, the opposing interior walls are configured to approximate together when the balloon structure is expanded, while in other cases, the compartments are configured to be pulled together after the balloon structure is expanded and traps the calcified leaflets therebetween.

[0263] In some cases, the feature comprises a plate, while in other cases, the feature comprises a protrusion on one of the opposing interior walls and a cavity on the other of the opposing interior walls, the protrusion configured to nest within the cavity when the opposing surfaces are deployed.

[0264] In yet another aspect, the present invention provides a method for affixing stress-applying features to the outer surface of a balloon, such as an angioplasty balloon, valvuloplasty balloon, or the like. The method includes providing a balloon having an outer surface and, optionally, forming a plurality of depressions over at least a portion of the outer surface of the balloon. An elastic adhesive is dispensed on the outer surface of the balloon and / or into each depression, and stress-applying features are placed on the elastic adhesive dispensed on the outer surface of the balloon and / or into each depression, displacing a portion of the elastic adhesive onto the outer surface of the balloon surrounding each plaque disruption feature. Each stress-applying feature is optionally coated with a spot layer of elastic adhesive, which forms a seal with the elastic adhesive displaced onto the outer surface of the balloon surrounding each plaque disruption feature. A cover layer of elastic polymer is then formed over at least the working length of the outer surface of the balloon and / or the sides of the balloon. Typically, one or more of the cover layer, elastic adhesive, plaque disruption features, and spot adhesive are coated, dispensed, or placed on the balloon after it has been expanded to the expanded configuration.

[0265] In a specific aspect, coating the exterior surface of the balloon with a cover layer of elastic polymer comprises coating the exterior surface with a curable elastic adhesive and curing the elastic adhesive.

[0266] In a specific aspect, the elastic adhesive dispensed on the exterior surface or within the recesses comprises a light-curable acrylic adhesive.

[0267] In a specific aspect, the spot layer comprises a light-curable acrylic adhesive. Typically, the elastic adhesive dispensed on the outer surface or in the recesses and spot layer comprises a chemically similar light-curable acrylic adhesive, and the two adhesives fuse together when cured.

[0268] In yet another aspect, the present invention provides a method for resisting balloon rupture in a calcified vessel, such as an angioplasty balloon, valvuloplasty balloon, or the like, comprising providing an outer surface of the balloon. The method includes providing a balloon having an outer surface. At least a working length of the outer surface of the balloon and / or sides of the balloon are coated with one or more base layers of an elastic polymer, which resist balloon rupture when the balloon is expanded in a calcified and / or hardened vessel or body lumen. In a specific aspect, coating the outer surface of the balloon with the base layer of an elastic polymer includes coating the outer surface with a curable elastic adhesive and curing the elastic adhesive.

[0269] In yet a further aspect, the present invention provides a device for treating a patient's valve having calcified valve leaflets, the device comprising: a catheter body having a proximal end and a distal end; and a compartmentalized expandable or non-expandable structure. The structure is disposed at the distal end of the catheter body, has opposing inner walls deployed or positioned on opposing surfaces of the valve leaflets, and configured to fracture calcification on the calcified valve when expanded and / or axially retracted together. Features on one or both of the opposing inner walls are configured to fracture calcified plaque on the valve leaflets as the opposing inner walls are deployed and / or axially retracted together.

[0270] In some cases, the opposing interior walls are configured to close together when the structure is expanded, while in other cases, the compartments are configured to be pulled together and trap the calcified leaflets therebetween.

[0271] In yet another further aspect, the present invention provides a device for treating a patient's valve having calcified valve leaflets. The device includes a catheter body having a proximal end and a distal end, and a segmented balloon structure disposed at the distal end of the catheter body. The segmented balloon structure has opposing inner walls configured to be deployed on opposing surfaces of the valve leaflets and to fracture calcification on the calcified valve. The two balloon sections are initially spaced apart on the catheter body and are configured to spread apart as the balloon sections are inflated so that the opposing inner walls converge and capture the calcified valve leaflets therebetween.

[0272] In yet a further aspect of the invention, stress-applying features may be attached to other expandable structures, such as inflatable balloons or cylindrically or conically shaped expandable structures, or stress-applying features may be attached to non-expandable structures using a “carrier” template. The carrier template may be fabricated, for example, by rolling or otherwise forming a thin, cylindrical base layer sized to be placed over the balloon or other cylindrically expandable or non-expandable structure in its deployed configuration, i.e., inflated or otherwise expanded state for an expandable structure. The base layer may typically be formed from a polymeric material, usually an elastic acrylic adhesive material, as described elsewhere herein. Alternatively, for non-expandable stress-applying features, the carrier template may be formed from a non-elastic structure, including metal, ceramic, non-stretchable polymer, and the like. The stress-applying features are attached to the outer surface of the carrier template, for example, by applying or dispensing adhesive at the locations where the stress-applying features will be positioned and pressing the features into the adhesive at those locations. The carrier template is then placed over the exterior surface of the structure, and the template is affixed to the exterior surface, typically using an adhesive, but alternatively by heat welding, ultrasonic fusing, or other conventional techniques.

[0273] In a further aspect, the present invention provides a device for treating an aortic valve having calcified leaflets extending between the sino-ascending junction and the valve annulus. The device includes a sleeve deployment catheter having a proximal end, a distal end, and a lumen extending through at least a distal region thereof. A leaflet capture sleeve is coupled to the distal end of the deployment catheter, the leaflet capture sleeve having a distal edge configured to engage the aortic side of the calcified leaflet, i.e., the side located at the sino-ascending junction. The lumen of the sleeve deployment catheter is configured to receive a valvuloplasty catheter and a balloon or other expandable valvuloplasty element on the sleeve deployment catheter, configured to be expanded against the ventricular side of the calcified leaflet, while the distal edge of the leaflet capture sleeve remains engaged against the aortic side of the calcified leaflet.

[0274] In a particular case, the distal edge of the leaflet capture sleeve may be rounded.

[0275] In particular cases, the distal edge of the leaflet capture sleeve may be contoured.

[0276] In a specific case, the distal edge of the leaflet capture sleeve may have a protrusion configured to be advanced beyond the sino-ascending junction toward the annulus between the commissures on the aortic side of the calcified leaflet.

[0277] In specific cases, the leaflet capture sleeve or a region of the sleeve deployment catheter proximal to the leaflet capture sleeve may include an embolic filter configured to allow blood from the aortic valve to flow out of the lumen, potentially containing harmful embolic material released as a result of expansion of the valvuloplasty element.

[0278] In particular cases, the filter element may comprise a mesh structure formed as at least a portion of the leaflet capture sleeve.

[0279] In particular cases, the filter element may comprise a fenestration formed in the wall of the catheter.

[0280] In particular cases, the filter element may comprise a mesh structure formed within the wall of the catheter.

[0281] In particular cases, the sleeve deployment catheter may include stressing features formed on at least a portion of the inner surface of the leaflet capture sleeve.

[0282] In another aspect, the device of the present invention may comprise a system including any one of the sleeve deployment catheters described and claimed in the specification in combination with a valvuloplasty catheter having a valvuloplasty element.

[0283] In a specific case, the valvuloplasty element comprises a balloon structure disposed at the distal end of the catheter.

[0284] In other cases, the valvuloplasty element comprises a mechanically expandable cage structure disposed at the distal end of the catheter.

[0285] In a specific case, the valvuloplasty catheter further comprises stress-applying features on the outer surface of the valvuloplasty element.

[0286] In another aspect, the present invention provides a method for treating an aortic valve having calcified leaflets extending between the sino-ascending junction and the annulus, wherein a distal edge of a leaflet capture sleeve is advanced from the aortic arch sinus toward the aortic arch junction, engaging the distal edge against the aortic side of at least some of the calcified leaflets, and a valvuloplasty element is advanced through the lumen of the leaflet capture sleeve, such that the valvuloplasty element on the valvuloplasty catheter is expanded against the ventricular side of at least some of the calcified leaflets while the distal edge of the leaflet capture sleeve remains engaged against the aortic side of at least some of the calcified leaflets.

[0287] In a specific aspect, advancing the distal edge of the leaflet capture sleeve includes advancing a deployment catheter having a proximal end, a distal end, and a lumen extending through at least a distal region thereof, and the leaflet capture sleeve is coupled to the distal end of the deployment catheter.

[0288] In a specific case, the distal edge may be rounded.

[0289] In particular cases, the distal edge may be contoured.

[0290] In a specific case, the distal edge may have a protrusion that, when the distal edge of the leaflet capture sleeve is advanced from the aortic arch sinus toward the ascending aortic junction, extends beyond the sinus-ascending aortic junction toward the annulus between the commissures on the aortic side of the calcified leaflet.

[0291] In specific cases, the method of the present invention may further include providing an embolic filter on the aortic side of the leaflet capture sleeve to allow blood from the aortic valve to flow out of the lumen, potentially containing harmful embolic material released as a result of expansion of the valvuloplasty element.

[0292] In particular cases, the filter element may comprise a mesh structure formed as at least a portion of the leaflet capture sleeve.

[0293] In particular cases, such a filter may comprise a fenestration formed in the wall of the catheter.

[0294] In particular cases, such a filter may comprise a mesh structure formed within the wall of the catheter.

[0295] In particular cases, the method of the present invention may further include providing stressing features on the inner surface of the leaflet capture sleeve.

[0296] In a particular case, expanding the annuloplasty element may include inflating a balloon structure.

[0297] In other cases, expanding the annuloplasty element may include mechanically expanding a cage structure.

[0298] In particular cases, the method of the present invention may further include providing stress-applying features on the outer surface of the annuloplasty element.

[0299] In a further aspect, the present invention provides an apparatus for treating calcifications on a wall within a body lumen of a patient, comprising a catheter, an expandable structure, and a plurality of needle-like stress-applying features distributed over at least a portion of the outer surface of the expandable structure, at least a distal portion of at least some of the needle-like stress-applying features having an atraumatic covering over their distal tips. The catheter typically includes a catheter body having a proximal end and a distal section. The expandable structure is disposed in the distal section of the catheter and has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall.

[0300] In a particular case, the expandable structure comprises an inflatable balloon.

[0301] In a specific case, at least some of the needle-like stress-applying features have sharp distal tips.

[0302] In a specific instance, the atraumatic cover is compressible so as to expose a sharp distal tip when the cover is pressed against the calcified plaque.

[0303] In a further aspect, the present invention provides an apparatus for treating calcifications on a wall within a body lumen of a patient, the apparatus comprising a catheter, an expandable structure, and a plurality of elongated blade-like stress-applying features. The catheter includes a catheter body having a proximal end and a distal section, the expandable structure being disposed in the distal section of the catheter body. The expandable structure has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall, and the plurality of elongated blade-like stress-applying features are distributed across at least a portion of the outer surface of the expandable structure. At least some of the blade-like stress-applying features have a compressible atraumatic covering thereover.

[0304] In a particular case, the expandable structure comprises an inflatable balloon.

[0305] In a specific case, the atraumatic cover covers the entire blade-like stress-applying feature, including the sharp edges, prior to the cover being compressed.

[0306] In other cases, sharp edges are exposed across the surface of the atraumatic covering prior to the covering being compressed.

[0307] The described illustrative aspects, examples, or embodiments are not meant to be limiting. For example, the examples provided for an implantable scaffold comprising a scaffold structure having a surface configured to be expanded within a patient's body can also be applied to other devices described herein, such as sleeves, balloons, cages, or the like.

[0308] In yet a further aspect of the present invention, an apparatus for treating calcifications on a wall in a body lumen of a patient includes a catheter, an expandable polymer balloon, and a plurality of discrete stress-applying features distributed across at least a portion of the balloon's outer surface. The catheter body has a proximal end and a distal end, and the expandable polymer balloon is attached to the distal end of the catheter body. The expandable polymer balloon has a hardness and an outer surface, and the plurality of discrete stress-applying features each have a hardness, a base, and a rounded, convex upper surface, and the discrete stress-applying features are distributed across at least a portion of the outer surface. At least a first polymer adhesive layer is disposed between the bases of the discrete stress-applying features and the outer surface of the expandable polymer balloon.

[0309] In a specific case, the first polymeric adhesive layer comprises a base layer configured to cover a continuous surface area of ​​the outer balloon surface, the continuous surface area being large enough to underlie at least a majority of the plurality of discrete stress-applying features, which are preferably distributed across the continuous surface area in both the axial and circumferential directions.

[0310] Typically, the continuous surface area is large enough to underlie at least a majority of the plurality of discrete stress-applying features, and preferably, the continuous surface area is large enough to underlie all of the plurality of discrete stress-applying features.

[0311] In some cases, the continuous surface region includes at least a cylindrical region (sometimes referred to as a working length or working surface) of the balloon's outer surface. For example, the cylindrical region of the continuous surface region may be located between tapered or conical end regions and / or curved transition regions of the balloon's outer surface.

[0312] In some cases, the continuous surface region may include at least one helical strip disposed across the cylindrical and / or tapered or conical region of the balloon.

[0313] In some cases, the continuous surface region may include at least one axial strip disposed across the cylindrical and / or tapered or conical region of the balloon.

[0314] In some cases, the continuous surface region comprises at least one circumferential band disposed across one or more of the cylindrical and / or tapered or conical regions of the balloon.

[0315] In some cases, the continuous surface region comprises a random two-dimensional pattern.

[0316] In some cases, the device further comprises a continuous surface of the balloon comprising a cylindrical surface, and the plurality of discrete stress-applying features are arranged in multiple circumferentially adjacent bands spaced axially along the cylindrical surface.

[0317] In some cases, the device further includes at least a second polymer adhesive layer disposed between the bottom of the discrete stress-applying feature and the outer surface of the inflatable polymer balloon. For example, the first polymer adhesive layer and the second polymer adhesive layer may both cover the same continuous surface area of ​​the outer balloon surface. Alternatively, or in addition, the first polymer adhesive layer and the second polymer adhesive layer may cover different continuous surface areas of the outer balloon surface.

[0318] In some cases, the first adhesive layer and the second adhesive layer each have a thickness that is no greater than 50% of the wall thickness of the inflatable polymer balloon.

[0319] In some cases, the second adhesive layer may comprise multiple adhesive spots, for example, each adhesive spot may be located beneath an individual discrete stress-applying feature and across the outer surface of the balloon.

[0320] In other cases, adhesive spots may be present across the first polymer adhesive layer and beneath the discrete stress-applying features.

[0321] In still other cases, adhesive spots may be present underneath both the first polymer adhesive layer and the discrete stress-applying features and across the outer surface of the balloon.

[0322] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer comprise the same adhesive polymer material.

[0323] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer comprise different adhesive polymer materials.

[0324] In some cases, the adhesive layer attached directly to the outer surface of the balloon is softer than the adhesive layer attached directly to the bottom of the stress-applying feature.

[0325] In some cases, the first polymeric adhesive layer and / or the second polymeric adhesive layer comprise one or more adhesive materials.

[0326] In some cases, the device of the present invention may further include a first polymer cover layer. For example, the first polymer cover layer may cover the outer surface of the balloon. For example, the first polymer cover layer may cover at least some of the plurality of discrete stress-applying features. For example, the first polymer cover layer may cover at least some of the first polymer adhesive layer. For example, the first polymer cover layer covers at least some of the first polymer adhesive layer.

[0327] In some cases, the first polymer cover layer comprises a polymer adhesive.

[0328] In some cases, the first polymer adhesive layer, when cured, may have a hardness less than that of the wall of the expandable polymer balloon and less than that of the discrete stress-applying features, and the first polymer adhesive is configured to accommodate differential expansion between the base of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated. For example, the discrete stress-applying features have a hardness of at least 4 Mohs, the polymer balloon wall has a Shore hardness in the range of 60D to 90D, and the first polymer adhesive has a Shore hardness in the range of 50D to 70D.

[0329] In some cases, the discrete stress-applying features may comprise at least one of a metal, a metal alloy, a mineral, a ceramic, and a hardened polymer. For example, the discrete stress-applying features may comprise a metal or metal alloy including at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

[0330] In some cases, the polymer balloon may comprise at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

[0331] In some cases, any one or more of the first polymeric adhesive layer, the second polymeric adhesive layer, and the first polymeric cover layer may comprise at least one of polymethacrylate, polyurethane-methacrylate, polyisobornyl acrylate, acrylic urethane methacrylate, methacrylate ester acrylic, modified methacrylate ester, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene vinyl acetate, polyethylene methyl acrylate, polyethylene, acrylic, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea-formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic glue, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, or a combination thereof.

[0332] In some cases, the device may further comprise at least a second polymer adhesive layer disposed between the bottom of the discrete stress-applying feature and the outer surface of the inflatable polymer balloon, the at least second polymer adhesive layer having, when cured, a hardness greater than or equal to that of the first polymer adhesive layer, which typically has a Shore hardness in the range of 50D to 70D.

[0333] In some cases, the first polymeric adhesive layer and the second polymeric adhesive layer may have the same hardness.

[0334] In other cases, the first polymeric adhesive layer and the second polymeric adhesive layer may have different hardnesses.

[0335] In some cases, the second polymer adhesive may comprise a spot adhesive. For example, the spot adhesive may be formed over the first polymer adhesive layer. Alternatively, or in addition, the spot adhesive may be formed under the first polymer adhesive layer.

[0336] In some cases, the first polymer cover layer may have a Shore hardness in the range of 50D to 70D.

[0337] In some cases, the devices of the present invention may further comprise a second polymeric cover layer formed over the exterior surface of the balloon and covering the plurality of discrete stress-applying features, e.g., the second polymeric cover layer comprises a polymeric adhesive.

[0338] In such cases, the first and second polymeric cover layers typically each have a thickness that is no greater than 50% of the wall thickness of the inflatable polymeric balloon.

[0339] In such cases, the second polymer cover layer typically has a Shore hardness in the range of 50D to 70D.

[0340] In a preferred embodiment, the balloon wall is made of a single layer of polymer material, for example, having a hardness ranging from 55D to 90D.

[0341] In some cases, the polymeric material of the balloon is a homogeneous composition material, i.e., has a uniform composition throughout most or all of the balloon structure.

[0342] In some cases, at least some of the plurality of discrete stress-applying features are formed as monolithic structures.

[0343] In other cases, at least some of the plurality of discrete stress-applying features are formed as polylithic structures.

[0344] In some cases, at least one of the first polymeric adhesive layer, the second polymeric adhesive layer, the first polymeric cover layer, and the second polymeric adhesive cover layer comprises a homogenous polymeric material, i.e., has a uniform composition throughout the majority of the balloon structure.

[0345] In some cases, at least one of the first polymeric adhesive layer, the second polymeric adhesive layer, the first polymeric cover layer, and the second polymeric adhesive cover layer comprises a reinforcement, a filler, a crosslinker, or an additive.

[0346] In some cases, the first polymeric adhesive layer and / or the second polymeric adhesive layer attach the bottom of the discrete stress-applying features to the outer surface of the inflatable polymeric balloon.

[0347] In some cases, each of the first polymeric adhesive layer, the second polymeric adhesive layer, the first polymeric adhesive cover, and / or the second polymeric adhesive cover comprises at least one polymer selected from the group consisting of polymethacrylate, polyurethane-methacrylate, polyisobornyl acrylate, acrylic urethane methacrylate, methacrylate ester acrylic, modified methacrylate ester, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene vinyl acetate, polyethylene methyl acrylate, polyethylene, acrylic, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea-formaldehyde, polyimide, natural or synthetic rubber modified with a tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic glue, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, and combinations thereof.

[0348] In yet a further aspect, the present invention provides an apparatus for treating calcification on a wall within a body lumen of a patient, the apparatus comprising: a catheter; an expandable polymeric balloon; a plurality of discrete stress-applying features distributed across at least a portion of the outer surface; and a polymer layer disposed across the outer surface of the expandable polymeric balloon. The catheter body has a proximal end and a distal end, and the expandable polymeric balloon is attached to the distal end of the catheter body. The expandable polymeric balloon has an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall, and a plurality of discrete stress-applying features, each having a hardness, a base, and a rounded, convex upper surface. The polymer layer is disposed between the bases of the discrete stress-applying features and the outer surface of the expandable polymeric balloon, the polymer layer covering a continuous surface area of ​​the outer balloon surface and being sufficiently large to be beneath at least a majority of the plurality of discrete stress-applying features distributed across the continuous surface area in both the axial and circumferential directions. A plurality of adhesive spots are deposited across the polymer layer to improve attachment of the bottom of each of the plurality of discrete stress-applying features to the polymer layer.

[0349] In some cases, the polymer layer is configured to both (a) adhere to the outer balloon surface and (b) accommodate the differential expansion between the base of the discrete stress-applying features and the outer surface of the inflatable polymer balloon as the balloon is inflated.

[0350] In some cases, the adhesive spots are configured to adhere to both the outer surface of the balloon and the bottom of the stress-applying feature.

[0351] In some cases, the adhesive spots are configured to both (a) adhere to the polymer layer and attach the stress-applying features to the outer balloon surface, and (b) further accommodate differential expansion between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymer balloon as the balloon is inflated.

[0352] In some cases, the adhesive spots are configured to adhere to the outer surface of the balloon and cover the stress-applying features.

[0353] In some cases, a polymer layer is disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon, with the multiple stress-applying features being distributed over a continuous surface area in both the axial and circumferential directions.

[0354] For example, multiple stress-applying features may be arranged across a continuous surface area in one or more axial strips, one or more circumferential bands, two or more spiral lines, two or more axial strips, two or more circumferential bands, two or more spiral lines, and / or a random two-dimensional grid.

[0355] In certain embodiments, the stress-applying features may be arranged in a grid pattern, with both the circumferential bands and axial strips having spacing or gaps between the features in both the circumferential and axial directions. Such spacing may be uniform or varying, regular or random.

[0356] In some cases, the continuous surface area is large enough to be beneath at least a majority of the plurality of discrete stress-applying features.

[0357] In some cases, the continuous surface area is large enough to be underneath all of the plurality of discrete stress-applying features.

[0358] In some cases, the polymer layer is inseparable from the outer surface of the balloon.

[0359] In some cases, the polymer layer is adhered to the outer balloon surface by one or more of the following: heat, fusion, welding, deposition, gluing, and the use of adhesives.

[0360] In some cases, the polymer layer may comprise, consist essentially of, or consist of a polymer adhesive material.

[0361] In some cases, the polymer layer may comprise a combination of adhesive and non-adhesive polymeric materials.

[0362] In some cases, the adhesive spots may comprise, consist of, or consist essentially of adhesive polymer material.

[0363] In some cases, the adhesive spots comprise a combination of polymeric adhesive materials and non-adhesive polymeric materials.

[0364] In yet another aspect, the present invention provides an apparatus for treating calcifications on a wall of a body lumen of a patient, the apparatus comprising: a catheter; an expandable polymeric balloon; a plurality of discrete stress-applying features distributed across at least a portion of the outer surface of the expandable polymeric balloon; a first polymer layer; and a second polymeric material. The catheter includes a catheter body having a proximal end and a distal end, and the expandable polymeric balloon is attached to the distal end of the catheter body. The expandable polymeric balloon has a hardness, and the outer surface is configured to be displaced radially outward toward the inner surface of the body lumen wall when the balloon is inflated. Each of the plurality of discrete stress-applying features has a hardness, a base, and a rounded, convex upper surface, and the discrete stress-applying features are distributed across at least a portion of the outer surface area in both the axial and circumferential directions. A first polymer layer is disposed between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymeric balloon, the first polymer layer covering a continuous surface area of ​​the outer balloon surface and being large enough to underlie at least a majority of the plurality of discrete stress-applying features. A second polymer material encapsulates at least the bottom of each of the plurality of stress-applying features and is attached to the first polymer layer.

[0365] In some cases, the second polymeric material is attached to the first polymeric material by one or more of heat, adhesive, fusing, solder, or combinations thereof.

[0366] In some cases, the first polymer layer and the second polymer material comprise the same material.

[0367] In some cases, the first polymeric layer and the second polymeric material comprise different materials.

[0368] In yet another aspect, the present invention provides a device for treating calcifications on a wall of a body lumen of a patient, the device comprising: a catheter; an expandable polymeric balloon; at least one layer comprising a plurality of discrete stress-applying features and a plurality of discrete polymer adhesive spots dispersed across at least a portion of the outer surface of the expandable polymeric balloon; a first polymer layer; and a second polymeric material. The catheter includes a catheter body having a proximal end and a distal end, and an expandable polymeric balloon attached to the distal end of the catheter body. The expandable polymeric balloon has a hardness, and the outer surface is configured to be displaced radially outward toward the inner surface of the body lumen wall when the balloon is inflated. Each of the plurality of discrete stress-applying features has a hardness, a base, and a rounded, convex upper surface, and the discrete stress-applying features are dispersed across at least a portion of the outer surface. Discrete polymer adhesive spots are disposed between the bottoms of the discrete stress-applying features and the outer surface of the expandable polymer balloon, and at least a first polymer adhesive layer is disposed over the outer surface of the expandable polymer balloon that overlaps at least a portion of at least one layer of the plurality of discrete polymer adhesives, the discrete polymer adhesive spots and the first polymer adhesive configured to accommodate differential expansion between the bottoms of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated.

[0369] In some cases, the plurality of discrete adhesive spots extend beyond the periphery of the bottom of the plurality of stress-applying features.

[0370] In some cases, the first polymeric adhesive layer covers at least one layer of the plurality of discrete polymeric adhesive spots.

[0371] In some cases, the first polymeric adhesive layer covers at least a portion of the plurality of discrete stress-applying feature surfaces.

[0372] In some cases, the plurality of discrete adhesive spots and the first polymeric adhesive layer comprise the same polymeric adhesive.

[0373] In some cases, the plurality of discrete adhesive spots and the first polymeric adhesive layer comprise different polymeric adhesives.

[0374] In some cases, at least a first polymer adhesive cover layer covers at least a portion of the plurality of discrete stress-applying feature surfaces.

[0375] In some cases, the first polymeric adhesive cover layer covers at least a portion of the first polymeric adhesive layer.

[0376] In some cases, the first polymeric adhesive cover layer covers at least a portion of the plurality of discrete stress-applying feature surfaces and at least a portion of the first polymeric adhesive layer.

[0377] In some cases, at least a first adhesive polymer layer covers part or all of the outer surface of a single-layer, homogeneous composition polymer balloon, and multiple stress-applying features are attached to the outer balloon surface by either the adhesive polymer layer and / or the adhesive spot layer. Both the at least a first adhesive polymer layer and the adhesive spot layer are typically softer than the balloon, and preferably do not have any stiffening members or other reinforcements attached to or embedded within the balloon. The balloon itself will also not have any parts or regions that are stiffer or otherwise different than the rest of the balloon. The balloon is optionally modified by adding adhesive polymer layers and / or adhesive spots and stress-applying features as described herein.

[0378] In some cases, the balloon is comprised of a single layer composition or material structure, which may be comprised of a single polymer, copolymer, or homogeneous mixture of polymer with metal or other hard, rigid, stress-applying features attached to the balloon through an adhesive polymer, such as the adhesive polymer layers and / or adhesive polymer spots described herein. There are no stiffening members attached to or embedded within the balloon, and no portion of the balloon itself is different or stiffer than the rest of the balloon.

[0379] Typically, the stress-applying features will be discrete metal structures with a rounded upper surface and a typically, but not always, flat bottom that is adhesively attached directly to the outer surface of the single-layer balloon, unmodified by stiffening elements or excess layers of balloon material. The polymer adhesive used to attach the stress-applying features is usually softer than the polymer of the polymer balloon.

[0380] In some cases, the discrete stress-applying features may be adhesively attached directly to the outer surface of the single layer polymer balloon.

[0381] In some cases, at least one polymer layer may be formed on the surface of the polymer balloon under a spot adhesive that attaches the discrete stress-applying features to the balloon. Each of these polymer layers is softer than the balloon, and alone or together, they seal the interface between the stress-applying features and the balloon, forming a buffer between the rigid discrete stress-applying features and the balloon. One or more polymer layers applied to the balloon form a compliant layer or barrier, allowing flexibility of the balloon as it traverses a body lumen and reducing the likelihood of moisture entering under the stress-applying features. These single or multiple intervening layers maintain the flexibility of the balloon, allowing it to conform to the passage of the body lumen and providing a stable structure for maintaining the discrete features in their position on the balloon during use in a physiological environment.

[0382] Although a polymer balloon will typically consist of a single, unmodified, homogeneous polymer layer, free of stiffeners, reinforcements, and other non-homogeneities, areas of the balloon wall not underlying stress-applying features may, in some cases, have multiple layers, reinforcements, or other non-homogeneities. However, those balloon areas underlying stress-applying features will, in preferred embodiments, preferably be free of any such non-homogeneities.

[0383] In yet a further aspect, the present invention provides an apparatus for treating calcifications on a wall of a body lumen of a patient, the apparatus comprising: a catheter, an inflatable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and an inflatable polymeric balloon attached to the distal end of the catheter body and having an outer balloon surface. Each of the plurality of discrete rigid stress-applying features is attached to the outer balloon surface and arranged in a first number of circumferential bands spaced axially along the length of the outer surface of the polymeric balloon. Each stress-applying feature within a band is circumferentially spaced, and at least some of the stress-applying features are axially offset from at least one (usually two) adjacent stress-applying features within the same band when the polymeric balloon is inflated.

[0384] In some cases, the plurality of discrete rigid stress-applying features may be further arranged in a second plurality of axially oriented strips disposed along the length of the outer surface of the balloon, and at least some of the stress-applying features in some or all of the axially oriented strips may be axially offset from the stress-applying features in circumferentially adjacent axially oriented strips when the balloon is inflated.

[0385] In some cases, the stress-applying features in some or all of the axially oriented strips may be axially offset from the stress-applying features in circumferentially adjacent axially oriented strips when the balloon is inflated.

[0386] In some cases, the stress-applying features on at least some of the axially oriented strips have the same axial spacing.

[0387] In some cases, the stress-applying features in all axially oriented strips have the same axial spacing.

[0388] In some cases, at least some of the stress-applying features in at least some circumferential bands may be axially offset from other stress-applying features in that circumferential band when the balloon is deflated to improve the crush force per stress-applying feature and / or prevent stacking of stress-applying features. Often, all of the stress-applying features in at least some circumferential bands are axially offset from other stress-applying features in that circumferential band. For example, each of the stress-applying features in each circumferential band may be axially offset from other stress-applying features in that circumferential band.

[0389] In some cases, each of the stress-applying features within the same circumferential band have the same circumferential spacing between them.

[0390] In some cases, the stress-applying features within at least some of the circumferential bands have the same circumferential spacing between them.

[0391] In some cases, at least some stress-applying features in at least one axial strip are axially offset from at least one stress-applying feature in a circumferentially adjacent axial strip.

[0392] In some cases, all stressing features are axially offset from at least some stressing features in at least one circumferentially adjacent axial strip. Often, all stressing features are axially offset from circumferentially adjacent stressing features in that circumferential band.

[0393] In some cases, all stress-applying features in each axial strip are axially offset from the stress-applying features in circumferentially adjacent axial strips.

[0394] In some cases, the stressing features have spacing from other stressing features on the balloon in both the axial and circumferential directions, which spacing may be the same or different in one or both directions.

[0395] In some cases, the multiple stress-applying features attached to the balloon in the circumferential bands and axial strips may form a pattern that is regular, irregular, random, spiral, or a combination thereof. The spacing between the stress-applying features may be uniform across the length of the balloon, the offset distance may be uniform, or the spacing may vary along the length of the balloon with different offsets.

[0396] Discrete stress-applying features may be attached to the balloon in a grid with various patterns. The axial strips of stress-applying features may be straight and / or parallel to each other along the length of the balloon, or they may have some features that are not straight along the longitudinal length of the balloon. Slightly axially offsetting the axial strips or rows of discrete stress-applying features from the stress-applying features within circumferentially adjacent axial strips improves the effectiveness of the features for fracture or crushing occlusions within a body lumen because the offset of the discrete stress-applying features better distributes the force of the features than if they were positioned in a circumferentially aligned band. The offset of the features provides more force, better distribution of the force, and a thinner profile of the features to reduce overlap of the features when the balloon is deflated. However, if the offset is too large, the ability to crack occlusions is reduced or eliminated. Ideally, the spacing of the features is between 0.05 mm and 0.5 mm to optimize the balloon's performance in fracture calcifications within a body lumen.

[0397] In some cases, at least some of the stress-applying features have convex rounded upper surfaces and rounded bases surrounding a center.

[0398] In some cases, the stress-applying features may have a width or diameter in the range of 0.15 mm to 1 mm, preferably 0.2 mm to 1 mm, typically 0.3 mm to 0.6 mm.

[0399] In some cases, the stress-applying features may be axially offset by a distance in the range of 0.3 mm to 2 mm, preferably 0.4 mm to 1.5 mm, typically 0.5 mm to 1 mm.

[0400] In some cases, circumferentially adjacent stressing features will be sufficiently axially spaced such that the peripheral edges of the circumferentially adjacent stressing features do not overlap axially, and the peripheral edges of circumferentially adjacent stressing features will have a gap between them in the range of 0 to 3 mm, typically 0 to 2 mm, and preferably 0.05 mm to 0.4 mm.

[0401] In some cases, all stress-applying features are sufficiently spaced apart so that when the expandable polymeric balloon is deflated, the peripheral edges of the stress-applying features do not axially overlap and have a gap between them in the range of 0 to 3 mm, typically 0 to 2 mm, and preferably 0.05 mm to 0.4 mm. For example, the width or diameter of each stress-applying feature, the axial offset between circumferentially adjacent stress-applying features, and the circumferential offset between axially adjacent stress-applying features are constant for all stress-applying features when the expandable polymeric balloon is inflated.

[0402] In some cases, the center of the stress-applying feature comprises the center of the bottom surface of the stress-applying feature.

[0403] In some cases, the center of the stress-applying feature comprises the center of the upper surface of the stress-applying feature.

[0404] In some cases, the axial and circumferential offsets are measured relative to the centers of adjacent stressing features.

[0405] In some cases, the density of the circumferential bands along the axial length ranges from 0.2 strips / mm of axial balloon length to 2 strips / mm of axial balloon length, preferably from 0.3 strips / mm of axial balloon length to 1 strip / mm of axial balloon length, and most preferably from 0.4 strips / mm of axial balloon length to 1 strip / mm of axial balloon length.

[0406] In some cases, the bases of axially adjacent stress-applying features in at least some of the axially oriented strips are axially spaced apart by a distance ranging from 0.5 mm to 3 mm, typically ranging from 1 mm to 2.5 mm, and preferably ranging from 1.5 to 2.5 mm.

[0407] In some cases, at least some of the discrete stress-applying features are formed as spheres, hemispheres, partial spheres, ellipsoids, or other shapes having convex, rounded upper surfaces.

[0408] In yet another aspect, the present invention provides an apparatus for treating calcifications on a wall of a body lumen of a patient, the apparatus comprising: a catheter, an expandable polymer balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and an expandable polymer balloon attached to the distal end of the catheter body and having an outer balloon surface. Each of the rigid stress-applying features is attached to the outer balloon surface, and at least some of the stress-applying features have a convex, rounded upper surface and a base attached directly or indirectly to the balloon surface. Most preferably, the peripheral edges of all of the stress-applying features do not overlap when the balloon is deflated.

[0409] In some cases, the peripheral edges of adjacent stress-applying features will have a gap between them in the range of 0 to 3 mm, typically 0 to 2 mm, and preferably 0.05 mm to 0.4 mm when the polymer balloon is deflated.

[0410] In yet a further aspect, the present invention provides an apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising a catheter, an expandable polymer balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and an expandable polymer balloon attached to the distal end of the catheter body and having an outer surface. The plurality of stress-applying features are attached to the outer surface of the polymer base layer, and the stress-applying features extend over at least an expanded region of the expandable polymer balloon when the expandable polymer balloon is fully inflated, with the stress-applying features being 0.1 to 5 features per outer surface area or a portion thereof (e.g., a cylindrical central section of the balloon) of the balloon. 2 ), preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 The distribution density is in the range of

[0411] In yet another aspect, the present invention provides an apparatus for treating calcifications on a wall of a body lumen of a patient, the apparatus comprising a catheter, an expandable polymer balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end, and an expandable polymer balloon attached to the distal end of the catheter body. The expandable polymer balloon has an outer surface, and a plurality of stress-applying features are attached to the outer surface of the expandable polymer balloon, the stress-applying features being spaced apart at least over an expanded region of the expandable polymer balloon when the expandable polymer balloon is fully inflated, with the stress-applying features being 0.1 to 5 features / mm 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 The distribution density is in the range of

[0412] In some cases, the expanded region of the inflatable polymer balloon comprises the entire expandable surface area of ​​the balloon.

[0413] In some cases, the expanded region of the inflatable polymer balloon comprises the central region of the balloon, excluding the tapered end regions of the balloon.

[0414] In yet a further aspect, the present invention provides an apparatus for treating calcification on a wall of a body lumen of a patient, the apparatus comprising: a catheter; an expandable polymer balloon; and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end. An expandable polymer balloon is attached to the distal end of the catheter body, the expandable polymer balloon having an outer surface. A plurality of stress-applying features are attached to the outer surface of the polymer balloon, each of the stress-applying features having a base region in contact with the outer surface of the expandable polymer balloon. The ratio of (1) the cumulative area of ​​all base regions in contact with the outer surface of the expandable polymer balloon to (2) the total area of ​​the outer surface of the expandable polymer balloon is within a range of 1:100 to 5:100, typically 2:100 to 5:100, and preferably 3:100 to 4:100.

[0415] In some cases, the outer surface of the inflatable polymer balloon may comprise the entire expandable surface area of ​​the balloon.

[0416] In other cases, the outer surface of the expandable polymer balloon comprises the central region of the balloon, excluding the tapered end regions of the balloon.

[0417] In some cases, the stress-applying features have a convex, rounded upper surface and a rounded base region that contacts the outer balloon surface.

[0418] In some cases, the stress-applying features all have the same dimensions.

[0419] In some cases, the stress-applying features are uniformly distributed across the outer surface of the expandable polymer balloon.

[0420] In yet an additional aspect, the present invention provides an apparatus for treating calcification on a wall of a body lumen of a patient, the apparatus comprising: a catheter, an expandable polymeric balloon, and a plurality of discrete rigid stress-applying features. The catheter includes a catheter body having a proximal end and a distal end. An expandable polymeric balloon is attached to the distal end of the catheter body, the expandable polymeric balloon having an outer surface. The plurality of stress-applying features are attached to the outer surface of the polymeric balloon. The catheter includes a catheter body having a proximal end and a distal end, and the expandable polymeric balloon has an outer surface with a central region, a tapered distal region, a tapered proximal region, a distal transition region between the distal tapered region and the central region, and a proximal transition region between the proximal tapered region and the central region. Individual stiffening features are attached to the outer surface of the expandable polymer balloon, and at least some of the stiffening features are distributed across at least a portion of one of: (a) a distal transition region, (b) a proximal transition region, (c) a distal tapered region, (d) a proximal tapered region, (e) a 2 mm length of the distal end of the central region, and (f) a 2 mm length of the proximal end of the central region of the outer surface of the expandable polymer balloon.

[0421] In some cases, at least some of the rigidity features have convex, rounded upper surfaces.

[0422] In some cases, the rigidity features have a width or diameter in the range of 0.15 mm to 1 mm, preferably 0.2 mm to 1 mm, and typically 0.3 mm to 0.6 mm.

[0423] In some cases, the discrete rigidity features comprise a metal or metal alloy comprising at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

[0424] In some cases, the expandable polymer balloon comprises a semi-compliant balloon having a nominal inflation pressure and a rated burst pressure, and the diameter of the central region of the balloon increases by a percentage in the range of 1% to 20%, typically 5% to 20%, and preferably 5% to 15% as the balloon is inflated from its nominal inflation pressure to its rated burst pressure.

[0425] In some cases, the polymer balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

[0426] In some cases, the expandable polymer balloon comprises a non-compliant balloon having a nominal inflation pressure and a rated burst pressure, and the diameter of the central region of the balloon increases by a percentage less than or equal to 5% as the balloon is inflated from its nominal inflation pressure to its rated burst pressure.

[0427] In some cases, at least some of the stiffening features are distributed across at least a portion of both the distal and proximal transition regions of the outer surface of the inflatable polymer balloon.

[0428] In some cases, at least some of the stiffening features are also distributed across at least a portion of both the tapered distal region and the tapered proximal region of the outer surface of the inflatable polymer balloon.

[0429] In some cases, at least some of the stiffening features are distributed over at least a portion of both the proximal and distal 1 mm lengths of the central region of the outer surface of the expandable polymer balloon.

[0430] In some cases, the stiffening features are arranged in circumferential bands across the outer surface of the expandable polymer balloon, for example, each circumferential band may include 2 to 8 stiffening features, typically 2 to 6 stiffening features, and preferably 3 to 5 stiffening features.

[0431] In some cases, some of the stiffening features are distributed throughout the central region of the outer surface of the expandable polymer balloon, and additional features are distributed throughout one or more of: (a) a distal transition region, (b) a proximal transition region, (c) a distal tapered region, and (d) a proximal tapered region. Distributing the stress-applying features on or throughout the transition and / or tapered regions of the balloon allows the stress-applying features to fracture or crack the calcification while preventing (eliminating or minimizing) damage to the adjacent vessel due to reduced, reduced, or eliminated "dog-boning" of the balloon adjacent to the calcification. Having the stress-applying features in a region of the balloon having a smaller circumference than the rest of the balloon allows the balloon to flex around the calcification without excessively distending or "ballooning" a portion of the balloon to a larger size and potentially angling the stress-applying features relative to the vessel wall. The stress-applying features on the transition and tapered regions provide forces that are still sufficient to break up the calcification, but with reduced damage to the vessel wall.

[0432] In some cases, all of the rigid features have the same shape and dimensions.

[0433] In some cases, the rigidity features on the central region have a shape and / or dimension that is different from the shape and / or dimension of the rigidity features on one or more of: (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, and (d) the proximal tapered region.

[0434] In some cases, the stiffening features are arranged in axial strips and circumferential bands in any or all of the regions.

[0435] In some cases, each axial strip consists of 2 to 8 rigid features.

[0436] In some cases, each circumferential band consists of 2 to 8 rigid features.

[0437] These and other embodiments are described in further detail in the following notes and accompanying description of the drawings.

[0438] Appendix 1. An intraluminal prosthesis, a scaffold composed at least in part of a non-degradable material and configured to expand from a crimped configuration to an expanded configuration; a plurality of stress-applying features coupled to an outer surface of the scaffold; Equipped with At least some of the stress-applying features have contact surfaces spaced outward from an outer surface of the scaffold, the blunt contact areas configured to disrupt occlusive material in a wall of the vascular lumen when the scaffold is expanded from a crimped configuration to an expanded configuration within the vascular lumen.

[0439] Clause 2. The endoluminal prosthesis of clause 1, wherein the scaffold has a tubular geometry.

[0440] Clause 3. The endoluminal prosthesis of Clause 2, wherein the tubular scaffold has a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, or a dog-bone shape.

[0441] Appendix 4. The endoluminal prosthesis of Appendix 1-3, wherein at least some of the blunt contact regions comprise a peripheral edge circumscribing the contact surface and configured to concentrate stress upon engagement against occlusive material on a wall of the vascular lumen when the scaffold is expanded from a crimped configuration to an expanded configuration within the vascular lumen.

[0442] Clause 5. The endoluminal prosthesis of clause 4, wherein the peripheral edge is formed by an intersection between the blunt contact area and a peripheral wall that at least partially surrounds the blunt contact area.

[0443] Appendix 6. The intraluminal prosthesis of Appendix 1-5, wherein the contact surface of the blunt contact area is flat, convex, rounded, or concave.

[0444] Clause 7. The endoluminal prosthesis of clause 6, wherein the contact surface of the blunt contact region is parallel to the outer surface of the scaffold.

[0445] Clause 8. The endoluminal prosthesis of clause 6, wherein the contact surface of the blunt contact region is angled relative to the outer surface of the scaffold.

[0446] Clause 9. The endoluminal prosthesis of clause 8, wherein the contact surface of the blunt contact region is inclined at an angle in the range of 5° to 45°, preferably 10° to 30°.

[0447] Clause 10. The endoluminal prosthesis of clauses 1-10, wherein the peripheral wall is oriented at an angle in the range of 75° to 105° relative to the contact surface of the blunt contact region.

[0448] Appendix 11. The endoluminal prosthesis of any one of appendices 4-10, wherein the peripheral edge extends completely around the contact surface of the blunt contact region and has a width in the range of 10 μm to 200 μm.

[0449] Clause 12. The endoluminal prosthesis of clause 11, wherein the peripheral edge is circular and the width comprises a diameter.

[0450] Clause 13. The endoluminal prosthesis of clauses 1-12, wherein at least some of the plurality of stress-applying features comprise one or more plates having a total thickness in the range of 0.25 mm to 1 mm and a width attached to the surface of the tubular scaffold in the range of 0.1 mm to 2 mm.

[0451] Appendix 14. The endoluminal prosthesis of Appendix 13, wherein at least some of the plates are configured as discs, stacked discs, truncated cones, stacked discs and truncated cones, ellipsoidal discs, and asymmetric cones.

[0452] Clause 15. The intraluminal prosthesis of clauses 1-12, wherein the scaffold comprises a plurality of struts joined by crowns.

[0453] Clause 16. The endoluminal prosthesis of clause 15, wherein the plurality of struts joined by the crowns are joined into a plurality of circumferential rings.

[0454] Item 17. The intraluminal prosthesis of item 15, wherein the plurality of struts joined by the crowns are joined in a spiral pattern.

[0455] Clause 18. The intraluminal prosthesis of clauses 13-17, wherein at least some of the stress-applying features are located at or adjacent to the crown.

[0456] Clause 19. The endoluminal prosthesis of clause 18, wherein at least some of the crowns carrying the stress-applying features are not joined to adjacent rings.

[0457] Clause 20. The endoluminal prosthesis of clause 18 or 19, wherein the stress-applying feature is located at or adjacent to the crown, respectively.

[0458] Clause 21. The endoluminal prosthesis of clauses 13-17, wherein at least some of the stress-applying features are located on struts between crowns or on one or more links joining adjacent rings.

[0459] Clause 22. The endoluminal prosthesis of clauses 1-21, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0460] Clause 23. The endoluminal prosthesis of clause 22, wherein successive diametrically opposed pairs of crowns are circumferentially offset.

[0461] Clause 24. The endoluminal prosthesis of clause 23, wherein successive diametrically opposed pairs of crowns are circumferentially offset by an angle of 45° to 90°.

[0462] Clause 25. The endoluminal prosthesis of clauses 1-21, wherein at least some of the stress-applying features are arranged in groups of three, which are circumferentially separated by approximately 120° about a circle on the surface of the tubular scaffold.

[0463] Clause 26. The endoluminal prosthesis of clauses 1-20, wherein at least some of the successive axially spaced stress-applying features are circumferentially offset by an angle in the range of 5° to 15°.

[0464] Clause 27. The endoluminal prosthesis of clause 26, wherein at least some consecutive circumferentially spaced stress-applying features are axially offset by an angle in the range of 5° to 15°.

[0465] Item 28. The endoluminal prosthesis of any one of Items 1-27, wherein the scaffold is formed by patterning a tubular substrate, laser cutting a tubular substrate, rolling a cut substrate, bending wire, or three-dimensional printing.

[0466] Clause 29. The endoluminal prosthesis of clauses 1-28, wherein the stress-applying features are preformed and attached by gluing, soldering, welding, threaded attachment, riveting, or crimping.

[0467] Clause 30. The endoluminal prosthesis of Clause 29, wherein the stress-applying features comprise preformed plates glued to the scaffold using an adhesive.

[0468] Clause 31. The endoluminal prosthesis of clauses 1-28, wherein the stress-applying features are formed in situ by three-dimensional printing, chemical vapor deposition, electrostatic deposition, molding, or folding of scaffold components.

[0469] Clause 32. The endoluminal prosthesis of clauses 1-28, wherein the stress-applying feature comprises a tab attached to the scaffold and folded over and onto an outer surface of the scaffold.

[0470] Clause 33. The intraluminal prosthesis of clauses 1-32, wherein the scaffold comprises a vascular stent or stent-graft.

[0471] Clause 34. The endoluminal prosthesis of clauses 1-32, wherein the scaffold comprises a prosthetic valve.

[0472] Clause 35. The endoluminal prosthesis of clauses 1-32, wherein the scaffold comprises a valvuloplasty device.

[0473] Clause 36. The endoluminal prosthesis of clauses 1-35, wherein the scaffold is balloon-expandable.

[0474] Item 37. The intraluminal prosthesis of Items 1-35, wherein the scaffold is self-expanding.

[0475] Clause 38. The endoluminal prosthesis of any one of clauses 1-37, wherein the stress-applying feature is configured to preferentially contact occlusive material within the wall.

[0476] Clause 39. The endoluminal prosthesis of clauses 1-38, wherein the scaffold comprises a sleeve configured to be placed over a stent or balloon, or to be self-expanding.

[0477] Clause 40. The endoluminal prosthesis of clauses 1-39, wherein the stress-applying feature comprises a sharp element protruding outward from the blunt contact region, the sharp element configured to concentrate stress upon engagement against occlusive material on a wall of the vascular lumen when the blunt contact region is pressed against a surface of the occlusive material.

[0478] Clause 41. The endoluminal prosthesis of clause 40, wherein the blunt surface extends above the surface of the scaffold a first distance and the sharp element protrudes from the surface of the blunt contact area a second distance equal to 0.05 mm to 0.1 mm of the first distance.

[0479] Item 42. The intraluminal prosthesis of item 41, wherein the second distance is within a range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0480] Clause 43. The intraluminal prosthesis of clauses 40-42, wherein the sharp element comprises a point.

[0481] Clause 44. The intraluminal prosthesis of clauses 40-42, wherein the sharp element comprises an edge.

[0482] Clause 45. A method for disrupting calcified plaque in a patient's vasculature, comprising: expanding a scaffold, comprised at least in part of a non-degradable material, from a crimped configuration to an expanded configuration within a calcified body vessel lumen; the scaffold comprising a plurality of stress-applying features secured to an outer surface thereof; at least some of the stress-applying features comprise blunt contact regions spaced outward from the outer surface and having a peripheral edge configured to disrupt occlusive material on a wall of the vascular lumen when the tubular scaffold is expanded within the vascular lumen from a crimped configuration to an expanded configuration; The stress application feature ruptures the occlusive material as the scaffold is expanded. method.

[0483] 46. ​​The method of claim 45, wherein the obstructing material comprises hardened plaque or calcification.

[0484] Item 47. The method of any one of items 45 to 46, wherein expanding the scaffold comprises expanding a balloon within the scaffold or allowing the scaffold to self-expand.

[0485] 48. The method of claim 45, wherein expanding the scaffold includes expanding the artificial prosthetic heart valve within the heart valve annulus, the scaffold providing structural support for the heart valve annulus.

[0486] 49. The method of claim 48, wherein expanding the prosthetic heart valve includes expanding a balloon to expand the prosthetic heart valve within the heart valve annulus.

[0487] 50. The method of claim 45, wherein expanding the scaffolding comprises expanding an annuloplasty device within the heart valve annulus.

[0488] Item 51. The method of item 50, wherein the scaffolding of the annuloplasty device comprises an expandable cage, and expanding the annuloplasty device comprises expanding the cage within the heart valve annulus.

[0489] Addendum 52. The method of any one of Addendums 45-51, wherein the tubular scaffold has a cylindrical shape, an ellipsoidal shape, a tapered profile, an hourglass shape, or a dog-bone shape.

[0490] Addendum 53. The method of any one of Addendums 45-52, wherein the peripheral edge is formed by an intersection between the blunt contact area and a peripheral wall that at least partially surrounds the blunt contact area.

[0491] Appendix 54. The blunt contact area is flat. The method of appendices 45-53.

[0492] Item 55. The method of item 54, wherein the blunt contact area is parallel to the outer surface of the tubular scaffold.

[0493] Item 56. The method of item 55, wherein the blunt contact area is inclined relative to the outer surface of the tubular scaffold.

[0494] Clause 57. The method of clauses 45-56, wherein the peripheral edge is formed by an intersection between the blunt contact area and a peripheral wall that at least partially surrounds the blunt contact area.

[0495] Addendum 58. The method of Addendum 57, wherein the blunt contact area is a plane.

[0496] Item 59. The method of item 57, wherein the peripheral wall is oriented at an angle within the range of 75° to 105° relative to the blunt contact area.

[0497] Item 60. The method of items 57-59, wherein the peripheral edge has a width in the range of 10 μm to 200 μm.

[0498] Addendum 61. The method of any one of Addendums 57-60, wherein at least some of the plurality of stress-applying features comprise one or more plates having a total thickness in the range of 0.5 mm to 1 mm and a surface width attached to the surface of the tubular scaffold in the range of 0.01 mm to 2 mm.

[0499] Addendum 62. The method of Addendum 61, wherein at least some of the plates are configured as disks, stacked disks, truncated cones, stacked disks and truncated cones, ellipsoidal disks, and asymmetric cones.

[0500] Addendum 63. The method of any one of Addendums 45-57, wherein the scaffold comprises a plurality of struts joined by a crown.

[0501] Item 64. The method of item 63, wherein the plurality of struts joined by crowns are joined into a plurality of circumferential rings.

[0502] Addendum 65. The method of Addendum 63, wherein the multiple struts joined by the crown are joined in a spiral pattern.

[0503] Clause 66. The method of clauses 63-65, wherein at least some of the stress-applying features are located at or adjacent to the crown.

[0504] Clause 67. The method of clause 66, wherein each stress-applying feature is located at or adjacent to a crown.

[0505] Clause 68. The method of clauses 63-65, wherein at least some of the stress-applying features are located on struts between the crowns.

[0506] Clause 69. The method of clauses 63-68, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0507] Addendum 70. The method of any one of Addendums 63-69, wherein successive diametrically opposed pairs of crowns are rotatably offset relative to the longitudinal axis of the scaffold.

[0508] Clause 71. The method of clause 70, wherein successive diametrically opposed pairs of crowns are rotatably offset relative to the longitudinal axis of the scaffold by an angle between 75° and 105°.

[0509] Appendix 72. A method for fabricating a vascular scaffold, the method comprising: patterning a tubular scaffold comprising a plurality of struts joined by crowns within a tubular envelope, the tubular scaffold having a plurality of tabs extending outward from the struts and / or crowns within the tubular envelope; folding the plurality of tabs over an outer surface of the tubular envelope to form a plurality of stress-applying features on the outer surface of the tubular scaffold; A method comprising:

[0510] Clause 73. The method of clause 72, wherein adjacent tabs of a pair are folded one over the other to form a stacked stress application feature.

[0511] Item 74. The method of item 73, wherein adjacent tabs within a pair are arranged side-by-side on the scaffold prior to folding.

[0512] Item 75. The method of item 73, wherein adjacent tabs within a pair are aligned in tandem on the scaffold prior to folding.

[0513] Clause 76. The method of clause 73, wherein adjacent tabs within a pair are arranged on opposite sides of the support post prior to folding.

[0514] Item 77. An apparatus for treating calcifications on a wall in a body lumen of a patient, the system comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of stress-applying features distributed across an outer surface of the expandable structure, at least some of the stress-applying features being on the outer surface of the expandable structure and having convex, rounded upper surfaces configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; An apparatus comprising:

[0515] Item 78. The device of item 77, wherein the body lumen comprises a blood vessel, a valve annulus, a venous valve, or an AV shunt.

[0516] Item 79. The device of any one of items 77 to 78, wherein the calcification is located within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0517] Clause 80. The device of any one of clauses 77-79, wherein the expandable structure is less rigid when unexpanded and more rigid when fully expanded.

[0518] Clause 81. The device of any one of clauses 77-80, wherein the outer surface of the expandable structure is generally cylindrical when fully expanded.

[0519] Addendum 82. The device of any one of Addendums 77-81, wherein the convex, rounded upper surfaces of the plurality of stress-applying features extend radially outward beyond the outer surface of the expandable structure when fully expanded.

[0520] Clause 83. The device of clause 82, wherein the convex, rounded upper surface of the plurality of stress-applying features, when fully expanded, extends radially outward beyond the outer surface of the expandable structure a distance ranging from 0.15 mm to 3 mm, preferably from 0.25 mm to 3 mm, and more preferably from 0.5 mm to 3 mm.

[0521] Addendum 84. The device of any one of Addendums 77-83, wherein the convex, rounded upper surface of the stress-applying features is free of edges and irregularities that could damage the wall when the expandable structure is expanded within a body lumen.

[0522] Addendum 85. The device of any one of Addendums 77-84, wherein at least some of the stress-applying features have a single convex, rounded upper surface and a lower base that is independently attached to the outer surface of the expandable structure.

[0523] Addendum 86. The apparatus of any one of Addendums 77-85, wherein at least some of the stress-applying features comprise spheres, hemispheres, truncated spheres, or ellipsoids.

[0524] Clause 87. The device of any one of clauses 77-86, wherein at least some of the stress-applying features are independently attached to the outer surface of the expandable structure.

[0525] Clause 88. The device of any one of clauses 77-87, wherein at least some of the stress-applying features comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure.

[0526] Item 89. The device of item 88, wherein the lower surface is flat.

[0527] Item 90. The device of item 88, wherein the lower surface is contoured.

[0528] Addendum 91. The device of any one of Addendums 77-88, wherein at least some of the stress-applying features comprise posts having a hemispherical upper surface and a lower surface attached to the outer surface of the expandable structure.

[0529] Addendum 92. The device of any one of Addendums 77-91, wherein the stress-applying feature comprises a sharp element protruding outward from the convex rounded upper surface, the sharp element configured to concentrate stress when engaged against a calcification on the wall of the vessel lumen when the convex rounded upper surface is pressed against the surface of the calcification.

[0530] Clause 93. The apparatus of clause 92, wherein the convex rounded upper surface extends above the surface of the scaffold a first distance and the sharp element protrudes from the surface of the convex rounded upper surface a second distance equal to 0.05 to 0.1 of the first distance.

[0531] Item 94. The device of item 92 or 93, wherein the second distance is within a range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0532] Clause 95. The device of clauses 92-94, wherein the sharp element comprises a point.

[0533] Clause 96. The device of clauses 92-94, wherein the sharp element comprises an edge.

[0534] Addendum 97. The device of any one of Addendums 77-96, wherein the expandable structure comprises an inflatable balloon.

[0535] Addendum 98. The device of Addendum 97, wherein the inflatable balloon has a central region, a distal tapered region, and a proximal tapered region, and the stress-applying feature is present on one or more of these regions.

[0536] Clause 99. The device of clause 97 or 98, wherein the stress-applying feature is present on at least the central region.

[0537] Clause 100. The device of clauses 97-99, wherein the stress-applying feature is present on at least one of the distal tapered region and the proximal tapered region.

[0538] Clause 101. The device of clause 100, wherein the stress-applying features are present on both the distal tapered region and the proximal tapered region.

[0539] Clause 102. The device of clauses 97-101, wherein the inflatable balloon has a compliance of less than 10% when inflated to a pressure of at least 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0540] Addendum 103. The device of any one of Addendums 77-102, wherein the stress-applying feature is attached to the outer surface of the expandable structure by at least one of adhesive bonding, ultrasonic welding, fusing, heat welding, interference fitting, solvent bonding, bonding with a polymeric material, use of fasteners, and combinations thereof.

[0541] Clause 104. The device of any one of clauses 77-103, further comprising an outer sleeve positioned over the stress-applying features on the outer surface of the expandable structure.

[0542] Clause 105. The device of clause 104, wherein the outer sleeve comprises a retractable sheath configured to shield the stress-applying features as the device is advanced and / or retracted through a body lumen.

[0543] Addendum 106. The device of Addendum 105, wherein the outer sleeve is positioned over the outer surface of the expandable structure and comprises an elastomeric tubular member that conforms to the stress application features when the expandable structure is expanded, the elastomeric tubular member being configured to expand and contract with the expandable structure.

[0544] Clause 107. The device of clause 104, wherein the elastomeric tubular member is laminated to or attached to at least a portion of the outer surface of the expandable structure.

[0545] Clause 108. The device of clause 104, wherein the outer sleeve comprises a non-stretchable or semi-compliant sheath that is folded over the balloon before the balloon is inflated.

[0546] Clause 109. The device of clauses 104-108, wherein the outer sleeve completely covers the clot-breaking features on the outer surface of the expandable structure.

[0547] Clause 110. The device of any one of clauses 104-109, wherein the outer sleeve comprises a polymer.

[0548] Clause 111. The apparatus of clauses 106-110, wherein at least some of the stress-applying features are attached to an inner surface of the elastomeric tubular member.

[0549] Clause 112. The device of clause 111, wherein at least some of the stress-applying features are formed as protrusions from the inner surface of the elastomeric tubular member.

[0550] Addendum 113. The device of any one of Addendums 77-112, wherein at least some of the stress-applying features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0551] Clause 114. The device of clause 113, wherein at least some of the bases have circular peripheries.

[0552] Clause 115. The device of clause 113, wherein at least some of the bases have oval peripheries.

[0553] Clause 116. The device of any one of clauses 77-115, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0554] Clause 117. The apparatus of clause 116, wherein successive diametrically opposed pairs of stress application features are circumferentially offset.

[0555] Clause 118. The apparatus of clause 117, wherein successive diametrically opposed pairs of stress application features are circumferentially offset by an angle between 45° and 90°.

[0556] Addendum 119. The device of any one of Addendums 77-115, wherein at least some of the stress-applying features are arranged in groups of three, which are circumferentially separated by approximately 120° about a circle on the surface of the expandable structure.

[0557] Addendum 120. The device of any one of Addendums 77-119, wherein the inflatable balloon is configured to release an inflation medium comprising a drug in response to an inflation pressure above a minimum threshold.

[0558] Clause 121. The apparatus of clause 120, wherein the minimum threshold is greater than 3 atm, 5 atm, or 7 atm.

[0559] Addendum 122. The device of any one of Addendums 120-121, wherein the inflatable balloon comprises a plurality of ports that open in response to inflation pressure above a minimum threshold.

[0560] Item 123. A method for treating calcifications on a wall in a body lumen of a patient, the method comprising: positioning the expandable structure at a treatment site adjacent the calcification to be treated; expanding the expandable structure radially outward to press a plurality of stress-applying features radially outward against the calcification, the stress-applying features being distributed across an outer surface of the expandable structure, at least some of the stress-applying features having convex, rounded upper surfaces, and pressing the plurality of stress-applying features radially outward against the calcification disrupts the calcification while reducing damage to the wall; A method comprising:

[0561] Addendum 124. The method of Addendum 123, wherein the body lumen comprises a blood vessel, a valve annulus, a venous valve, or an AV shunt.

[0562] Item 125. The method of any one of items 123 to 124, wherein the calcification is located within the inner wall, intimal layer, medial layer, adventitial layer, valve leaflet, valve annulus, venous filter, or implant.

[0563] Addendum 126. The method of any one of Addendums 123-125, wherein the convex, rounded upper surface of the stress-applying feature is free of edges and irregularities that may damage the blood vessel wall when the expandable structure is expanded within the body lumen.

[0564] Addendum 127. The method of any one of Addendums 123-126, wherein the stress-applying feature comprises a sharp element protruding outward from the rounded upper surface of the convex surface, the sharp element configured to concentrate stress when engaged against a calcification on a wall of the vessel lumen when the rounded upper surface of the convex surface is pressed against the surface of the calcification.

[0565] Addendum 128. The method of Addendum 127, wherein the convex rounded upper surface extends above the surface of the scaffold by a first distance and the sharp element protrudes from the surface of the convex rounded upper surface by a second distance equal to 0.05 to 0.1 of the first distance.

[0566] Addendum 129. The method of Addendum 127 or 128, wherein the second distance is in the range of 0.01 mm to 0.2 mm or 0.01 mm to 0.1 mm.

[0567] Addendum 130. The method of any one of Addendums 127-129, wherein the sharp element comprises a point.

[0568] Addendum 131. The method of any one of Addendums 127-129, wherein the sharp element comprises an edge.

[0569] Clause 132. The method of any one of clauses 123-131, wherein expanding comprises inflating a balloon having multiple stress-applying features independently attached to the outer surface of the balloon.

[0570] Clause 133. The method of any one of clauses 123-132, wherein at least some of the stress-applying features comprise spheres or ellipsoids having lower surfaces attached to the exterior surface of the expandable structure.

[0571] Clause 134. The method of any one of clauses 123-132, wherein at least some of the stress-applying features comprise hemispheres having lower surfaces attached to the outer surface of the expandable structure.

[0572] Addendum 135. The method of any one of Addendums 123-132, wherein at least some of the stress-applying features comprise posts having hemispherical upper surfaces and lower surfaces attached to the outer surface of the expandable structure.

[0573] Clause 136. The method of any one of clauses 123-135, wherein the lower surface is directly attached to the outer surface of the expandable structure.

[0574] Clause 137. The method of any one of clauses 123-135, wherein the lower surface comprises a base that is directly attached to the outer surface of the expandable structure.

[0575] Addendum 138. The method of any one of Addendums 123-137, wherein at least some of the stress-applying features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0576] Clause 139. The method of clause 138, wherein at least some of the bases have circular peripheries.

[0577] Addendum 140. The method of Addendum 138, wherein at least some of the bases have oval peripheries.

[0578] Clause 141. The method of any one of clauses 123-140, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0579] Clause 142. The method of clause 141, wherein successive diametrically opposed pairs of stress application features are circumferentially offset.

[0580] Clause 143. The method of clause 142, wherein successive diametrically opposed pairs of stress application features are circumferentially offset by an angle between 45° and 90°.

[0581] Addendum 144. The method of any one of Addendums 123-140, wherein at least some of the stress-applying features are arranged in groups of three, which are separated circumferentially by approximately 120° about a circle on the surface of the expandable structure.

[0582] Clause 145. The method of any one of clauses 123-144, wherein expanding the expandable slit structure radially outward comprises inflating an inflatable balloon.

[0583] Item 146. The method of item 145, wherein the inflatable balloon has a compliance of less than 10% when inflated to 8 atm, at least 10 atm, at least 12 atm, at least 16 atm, at least 18 atm, or at least 20 atm.

[0584] Addendum 147. The method of any one of Addendums 145-146, wherein the inflatable balloon is inflated to a pressure by pressing the convex, rounded upper surface of the stress-applying feature against the inner wall of the body lumen without engaging the outer surface of the inflatable balloon against the inner wall of the body lumen.

[0585] Clause 148. The method of any one of clauses 145-147, wherein prior to inflation, the inflatable balloon remains sufficiently flexible to be advanced through a body lumen.

[0586] Addendum 149. The method of any one of Addendums 123-148, wherein the stress-applying feature is attached to the exterior surface of the expandable structure by at least one of adhesive, ultrasonic welding, heat welding, fasteners, solvent bonding, bonding with a polymeric material, or a combination thereof.

[0587] Clause 150. The method of any one of clauses 123-149, further comprising an outer sleeve positioned over the stress-applying features on the outer surface of the expandable structure.

[0588] Clause 151. The method of clause 150, wherein the outer sleeve comprises a retractable sheath configured to shield the stress-applying feature as the expandable member is advanced and / or retracted through the body lumen.

[0589] Addendum 152. The method of Addendum 150, wherein the outer sleeve comprises an elastomeric tubular member positioned over the outer surface of the expandable structure and conforming to the stress-applying features, the elastomeric tubular member configured to expand and contract with the expandable structure, and the stress-applying features remain configured to fracture the plaque when expanded against the plaque.

[0590] Clause 153. The method of clause 152, wherein the elastomeric tubular member is laminated to at least a portion of the outer surface of the expandable structure.

[0591] Clause 154. The method of clause 150, wherein the outer sleeve comprises a non-stretchable or semi-compliant sheath that is folded over the balloon before the balloon is inflated.

[0592] Clause 155. The method of clauses 123-154, wherein the outer sleeve completely covers the clot-breaking features on the outer surface of the expandable structure.

[0593] Clause 156. The method of clauses 153-155, wherein at least some of the stress-applying features are attached to an interior surface of the elastomeric tubular member.

[0594] Clause 157. The method of clause 156, wherein at least some of the stress-applying features are formed as protrusions from an inner surface of the elastomeric tubular member.

[0595] Addendum 158. The method of any one of Addendums 123-155, wherein at least some of the stress-applying features have a base attached to the outer surface of the expandable structure, the base having an axial width (Wa) and a circumferential width (Wc), wherein the width ratio Wa:Wc is in the range of 1:0.5 to 1:5, typically 1:1 to 1:5, and more typically 1:1 to 3:1.

[0596] Clause 159. The method of clause 158, wherein at least some of the bases have circular peripheries.

[0597] Clause 160. The method of clause 158, wherein at least some of the bases have oval peripheries.

[0598] Clause 161. The method of any one of clauses 123-160, wherein at least some of the stress-applying features are arranged in diametrically opposed pairs.

[0599] Clause 162. The method of clause 161, wherein successive diametrically opposed pairs of stress application features are circumferentially offset.

[0600] Clause 163. The method of clause 162, wherein successive diametrically opposed pairs of stress application features are circumferentially offset by an angle between 45° and 90°.

[0601] Addendum 164. The method of any one of Addendums 123-160, wherein at least some of the stress-applying features are arranged in groups of three, which are circumferentially separated by approximately 120° about a circle on the surface of the expandable structure.

[0602] Addendum 165. The method of any one of Addendums 123-164, wherein the stress-applying features are arranged in a number of circumferential ring patterns, each ring pattern including 1 to 10 features, preferably ranging from 2 to 5 features, and more preferably ranging from 3 to 4 features.

[0603] Clause 166. The method of clause 165, wherein the circumferential ring patterns are axially spaced across the length of the expandable structure and separated by gaps in the range of 0.1 mm to 3 mm.

[0604] Item 167. The method of item 165 or 166, wherein the number of features ranges from 2 to 200 per mm of axial length.

[0605] Clause 168. The method of any one of clauses 123-167, further comprising releasing an inflation medium comprising a drug through the inflatable balloon in response to an inflation pressure above a minimum threshold.

[0606] Item 169. The method of item 168, wherein the minimum threshold is greater than 3 atm, 5 atm, or 7 atm.

[0607] Addendum 170. The method of any one of Addendums 168 or 169, wherein the inflatable balloon comprises a plurality of ports that open in response to an inflation pressure above a minimum threshold.

[0608] Item 171. A device for treating a valve in a patient having calcified valve leaflets, the device comprising: a catheter body having a proximal end and a distal end; a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to expand over opposing surfaces of the valve leaflets and to fracture calcifications on the calcified valve; An apparatus comprising:

[0609] Item 172. The device of item 171, wherein the opposing inner walls are configured to approximate each other when the balloon structure is expanded.

[0610] Item 173. The device of item 172, wherein the opposing inner walls are configured to nest when the balloon structure is expanded.

[0611] Clause 174. The apparatus of clause 173, wherein the nested opposing inner walls comprise nested conical surfaces.

[0612] Addendum 175. The device of Addendum 172, wherein the opposing inner walls comprise flat surfaces configured to approach each other when the balloon structure is expanded.

[0613] Addendum 176. The device of Addendum 175, wherein the compartmentalized balloon structure comprises a pair of opposing conical balloons having flat bases with flat surfaces.

[0614] Clause 177. The device of clauses 171-176, further comprising a plurality of calcification-fragmenting features distributed across at least one of the opposing interior walls of the compartmentalized balloon structure.

[0615] Item 178. The device of item 177, wherein the calcification crushing features are distributed across both opposing interior walls of the compartmentalized balloon structure.

[0616] Addendum 179. The device of Addendum 177 or 178, wherein at least some of the calcification-breaking features have convex, rounded leaflet-engaging surfaces configured to break up calcifications while minimizing damage to the leaflets when the balloon structure is expanded within the patient's valve.

[0617] Addendum 180. The device of any one of Addendums 177-179, wherein the convex, rounded upper surfaces of the plurality of stress-applying features are configured to extend from opposing inner walls of the expandable balloon when the balloon is inflated.

[0618] Item 181. The device of item 180, wherein the convex, rounded upper surface extends from the opposing inner wall a distance in the range of 0.1 mm to 3 mm, preferably 0.25 mm to 3 mm, and more preferably 0.5 mm to 3 mm, when the balloon is fully inflated.

[0619] Addendum 182. The device of any one of Addendums 204-206, wherein the convex, rounded upper surface of the calcification-breaking feature is free of edges and irregularities that could damage the valve leaflets when the balloon structure is inflated within the patient's valve.

[0620] Clause 183. The device of clauses 179-182, wherein the calcification-breaking feature comprises a sharp element protruding outward from the convex rounded upper surface, the sharp element configured to concentrate stress when pressed against the surface of the leaflet and engaged against calcification on the leaflet.

[0621] Clause 184. The device of any one of clauses 171-183, wherein the balloon section is fixed onto the catheter body with a fixed spacing between opposing inner walls.

[0622] Clause 185. The device of any one of clauses 171-183, wherein the balloon sections are configured for axial translation relative to one another on the catheter body with variable spacing between opposing inner walls.

[0623] Clause 186. The device of any one of clauses 171-185, wherein the calcification fracture features on the opposing surfaces are axially aligned as the balloon segments are pulled together.

[0624] Clause 187. The device of any one of clauses 171-186, wherein the calcification fracture features on the opposing surfaces are offset laterally so that the balloon segments are not axially aligned as they are pulled together.

[0625] Item 188. A method for treating a valve in a patient having calcified valve leaflets, the method comprising: providing a catheter body having a compartmentalized balloon structure disposed at a distal end thereof; advancing the segmented balloon structure intravascularly to the patient's valve; expanding opposing inner walls of the segmented balloon over opposing surfaces of the valve leaflets to disrupt calcifications on the calcified valve; A method comprising:

[0626] Clause 189. The method of clause 188, wherein the opposing inner walls are configured to approximate together when the balloon structure is expanded.

[0627] Item 190. The method of item 189, wherein the opposing inner walls are configured to nest when the balloon structure is expanded.

[0628] Clause 191. The method of clause 189, wherein the nested opposing interior walls comprise nested conical surfaces.

[0629] Addendum 192. The method of Addendum 189, wherein the opposing inner walls comprise flat surfaces configured to approach each other when the balloon structure is expanded.

[0630] Addendum 193. The method of Addendum 192, wherein the compartmentalized balloon structure comprises a pair of opposing conical balloons having flat bases with flat surfaces.

[0631] Clause 194. The method of clauses 188-193, wherein the plurality of calcification fracture features are distributed across at least one of the opposing interior walls of the compartmentalized balloon structure.

[0632] Item 195. The method of item 194, wherein the calcification fracture features are distributed across both opposing interior walls of the compartmentalized balloon structure.

[0633] Addendum 196. The method of any one of Addendums 188-195, wherein at least some of the calcification-breaking features have convex, rounded leaflet-engaging surfaces configured to break up calcifications while minimizing damage to the leaflets when the balloon structure is expanded within the patient's valve.

[0634] Addendum 197. The method of any one of Addendums 194-196, wherein the convex, rounded upper surfaces of the plurality of stress-applying features are configured to extend from opposing inner walls of the expandable balloon when the balloon is inflated.

[0635] Addendum 198. The method of Addendum 197, wherein the convex rounded upper surface extends from the opposing inner wall by a distance ranging from 0.25 mm to 3 mm, preferably 0.5 mm to 3 mm, when the balloon is fully inflated.

[0636] Addendum 199. The method of any one of Addendums 196-198, wherein the convex, rounded upper surface of the calcification fracture feature is free of edges and irregularities that may damage the valve leaflets when the balloon structure is inflated within the patient's valve.

[0637] Addendum 200. The method of any one of Addendums 196-198, wherein the calcification-breaking feature comprises a sharp element protruding outward from the convex rounded upper surface, the sharp element configured to concentrate stress when pressed against the surface of the leaflet and engaged against calcification on the leaflet.

[0638] Clause 201. The method of any one of clauses 188-200, wherein the balloon section is fixed on the catheter body with a fixed spacing between opposing inner walls.

[0639] Addendum 202. The method of any one of Addendums 188-200, wherein the balloon segments are configured to translate axially relative to one another on the catheter body, and further comprising, after the balloon structure is inflated, moving the balloon segments together to compress the wall surfaces against the valve leaflets.

[0640] Item 203. A method for disrupting calcification or plaque in a lesion, the method comprising: advancing the sleeve over the wire and through the lesion; advancing an expandable member over the wire into the interior of the sleeve; expanding the expandable member within the sleeve to radially displace features on the interior and / or exterior of the sleeve outwardly relative to the lesion to disrupt the calcification or plaque; A method comprising:

[0641] Clause 204. The method of clause 203, further comprising removing the expandable member from the sleeve and removing the expandable member and sleeve over the wire.

[0642] Clause 205. The method of clause 204, wherein the expandable structure is a balloon or other expandable member.

[0643] Clause 206. The method of clause 203, wherein the expandable structure comprises a stent, and the sleeve is left in place between the stent and the lesion after the stent is expanded.

[0644] Clause 207. The method of any one of clauses 203-206, wherein the stress-applying features protrude radially outward from the sleeve into the vessel wall when the expandable structure displaces them radially outward in response to expansion.

[0645] 208. A method for disrupting calcification or plaque in a lesion, the method comprising: advancing a cage or basket over the wire and across the lesion; expanding a cage of the basket to radially displace stress-applying features on the cage or basket relative to the lesion to fracture the calcification or plaque; A method comprising:

[0646] 209. The method of claim 208, wherein expanding the cage or basket includes mechanically reorienting structural components of the cage or basket.

[0647] 210. The method of claim 208, wherein expanding the cage or basket includes inflating a balloon within the cage or basket.

[0648] 211. The method of claim 210, wherein the balloon is advanced with a cage or basket through the lesion.

[0649] 212. The method of claim 210, wherein the balloon is advanced into the lesion after the cage or basket.

[0650] Item 213. A device for treating calcifications on a wall in a body lumen of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of stress-applying features distributed across an outer surface of the expandable structure, at least some of the stress-applying features being disposed on the outer surface of the expandable structure and having convex, rounded apexes configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; Equipped with The convex rounded peaks of the stress-applying features, when the expandable structure is expanded, have a radial height above the outer surface of the expandable structure ranging from a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and a number of features ranging from 0.1 to 5 per mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2and a distribution density in the range of

[0651] Clause 214. The device of clause 213, wherein the stress-applying feature has a footprint having a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0652] Clause 215. The apparatus of clause 213 or 214, wherein the stress-applying feature comprises any one or more of the following solid bodies: a ball, a sphere, a hemisphere, a partial sphere, a dome, and an ellipsoid.

[0653] Clause 216. The apparatus of clauses 213-215, wherein the stress-applying feature is solid.

[0654] Clause 217. The apparatus of clauses 213-215, wherein the stress application feature is hollow.

[0655] Clause 218. The device of any one of clauses 213-217, further comprising an encapsulation layer covering the outer surface of the expandable structure and the stress-applying features and immobilizing the stress-applying features in a desired pattern on the outer surface of the expandable structure.

[0656] Clause 219. The apparatus of Clause 218, wherein the stress-applying features comprise discrete bodies.

[0657] Clause 220. The apparatus of Clause 219, wherein the discrete bodies comprise metal.

[0658] Clause 221. The apparatus of clauses 218-220, wherein the stress-applying feature is immobilized solely by the encapsulation layer.

[0659] Clause 222. The device of clauses 218-220, wherein the stress-applying feature is secured by an encapsulation layer as well as an adhesive between the feature and the exterior surface.

[0660] Clause 223. The apparatus of clauses 218-222, wherein the encapsulation layer encapsulates the entire stress-applying feature, including the rounded peak of the convex surface.

[0661] Clause 224. The apparatus of clauses 218-222, wherein the encapsulation layer encapsulates only a lower portion of the stress-applying feature, excluding the rounded apex of the convex surface.

[0662] Clause 225. The device of any one of clauses 213-224, wherein the stress-applying features are supported within recesses in the outer surface of the expandable structure.

[0663] Clause 226. The apparatus of clauses 213-225, wherein the encapsulation layer comprises a polymer selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA).

[0664] Addendum 227. The apparatus of any one of Addendums 218-226, wherein the encapsulation layer is applied over the exterior surface and stress-applying features by any one of coating, direct fluid application, lamination, and fusing.

[0665] Clause 228. The apparatus of clauses 218-227, wherein the encapsulation layer has a thickness in the range of 0.01 mm to 0.1 mm (0.4 mils to 4 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0666] Clause 229. The device of any one of clauses 213-228, wherein the stress-applying feature is disposed within a recess formed in the outer surface of the expandable structure.

[0667] Clause 230. The device of clauses 213-229, wherein the stress-applying feature is constrained across the exterior surface of the expandable structure by an elastic sleeve.

[0668] Clause 231. The device of Clause 230, wherein the stress-applying feature is further attached to an outer surface of the expandable structure.

[0669] Clause 232. The apparatus of Clause 230, wherein the stress-applying feature is attached to an inner surface of the elastic sleeve.

[0670] Clause 233. The device of any one of clauses 213-228, wherein the stress-applying features are mounted on posts that are hollow and project radially outward from the outer surface of the expandable structure.

[0671] Item 234. A device for treating calcifications on a wall in a body lumen of a patient, the device comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall; a plurality of stress-applying features distributed across an outer surface of the expandable structure, at least some of the stress-applying features being on the outer surface of the expandable structure and having upper surfaces configured to disrupt calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen; an encapsulation layer covering the exterior surface of the expandable structure and at least a portion of the stress-applying features and immobilizing the stress-applying features on the exterior surface of the expandable structure in the desired pattern; An apparatus comprising:

[0672] Clause 235. The apparatus of clause 234, wherein at least some of the upper surfaces of the stress-applying features comprise convex, rounded peaks.

[0673] Clause 236. The apparatus of clause 234 or 235, wherein the encapsulation layer covers the entire outer surface of at least some of the stress-applying features, including the upper surface.

[0674] Clause 237. The apparatus of clause 234 or 235, wherein the encapsulation layer covers only lower portions of the outer surfaces of at least some of the stress-applying features.

[0675] Clause 238. The device of any one of clauses 234-237, wherein the stress-applying feature is disposed within a recess on the outer surface of the expandable structure.

[0676] Clause 239. The device of Clause 234, wherein the stress-applying feature comprises a hemisphere with a flat bottom bonded to the outer surface of the expandable structure.

[0677] Clause 240. The apparatus of any one of clauses 234-239, wherein the stress-applying features comprise discrete bodies.

[0678] Clause 241. The apparatus of Clause 240, wherein the discrete bodies comprise metal.

[0679] Clause 242. The apparatus of clauses 234-240, wherein the stress-applying feature comprises any one or more of a ball, a sphere, a hemisphere, a partial sphere, an ellipsoidal solid body, and a dome.

[0680] Clause 243. The apparatus of clauses 234-242, wherein the stress-applying feature is immobilized solely by the encapsulation layer.

[0681] Clause 244. The apparatus of clauses 234-243, wherein the stress-applying feature is secured by an encapsulation layer and an adhesive between the feature and the exterior surface.

[0682] Clause 245. The apparatus of clauses 234-244, wherein the encapsulation layer comprises a polymer selected from the group consisting of thermoplastic fluoropolymer (PVDF), butyl methacrylate (PBMA), and thermoplastic polyester (PLLA).

[0683] Addendum 246. The apparatus of any one of Addendums 234-245, wherein the encapsulation layer is applied over the exterior surface and stress-applying features by any one of coating, direct fluid application, lamination, and fusing.

[0684] Clause 247. The apparatus of clauses 234-246, wherein the encapsulation layer has a thickness in the range of 0.01 mm to 0.1 mm (0.4 mils to 4 mils), often 0.01 mm to 0.05 mm (0.4 mils to 2 mils), and more often 0.01 mm to 0.02 mm (0.4 mils to 0.8 mils).

[0685] Addendum 248. The convex rounded apexes of the stress-applying features, when the expandable structure is expanded, have a minimum radial height of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm above the outer surface of the expandable structure, and a number of features per mm ranging from 0.1 to 5. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density in the range of

[0686] Addendum 249. The device of Addendum 248, wherein the plaque distribution characteristic has a footprint having a maximum width, diameter, or other lateral dimension of 4 mm or less, often 3 mm or less, more often 1 mm or less, frequently 0.75 mm or less, and sometimes 0.5 mm or less.

[0687] Item 250. A method for treating a lesion on a wall in a body lumen of a patient, comprising: providing a catheter having an expandable structure disposed at a distal end thereof, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of a body lumen wall, the outer wall having a plurality of spatial separation features distributed across the outer surface of the expandable structure; expanding the expandable structure within the patient's body lumen such that a radially outward force is applied by the outer surface and the features against the wall, while the features maintain a gap between the outer surface of the expandable structure and the inner wall; A method comprising:

[0688] Clause 251. The method of clause 250, wherein the spacer feature has axially aligned through holes that allow the passage of contrast agent therethrough.

[0689] Clause 252. The method of clause 277 or 278, wherein the gap allows fluid perfusion through and beyond the expandable structure while the expandable structure is expanded.

[0690] Clause 253. The method of clause 277 or 278, further comprising perfusing a drug into the gap while the expandable structure is expanded.

[0691] 254. The method of claim 253, wherein the expandable structure comprises a balloon and the drug is perfused through the wall of the balloon.

[0692] Clause 255. The method of clause 254, wherein at least some of the spatial separation features comprise a drug that is released into the interstices.

[0693] Addendum 256. The method of any one of Addendums 250-255, wherein expanding the expandable structure creates one or more gaps between an outer surface and an inner wall of the expandable structure under physiological pressure, allowing fluid perfusion through the one or more gaps.

[0694] 257. The method of any one of claims 250-256, wherein the body lumen comprises a blood vessel and the body fluid perfusion comprises blood.

[0695] 258. The method of claim 257, wherein the fluid perfusion further includes at least one of a contrast agent and a drug.

[0696] Addendum 259. The method of any one of Addendums 250-258, wherein at least some of the features have convex, rounded peaks.

[0697] Addendum 260. The features, when the expandable structure is expanded, have a radial height above the outer surface of the expandable structure ranging from a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, or 0.25 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm, and a number of features between 0.1 and 5 per mm. 2 , preferably 0.2 to 4 features / mm 2 , more preferably 0.25 to 3 features / mm 2 and a distribution density within the range of

[0698] Addendum 261. The method of any one of Addendums 250-260, wherein the expandable structure is expanded with a force sufficient to create and / or maintain one or more gaps against a physiological pressure of 0.5 psi to 5 psi, preferably 1 psi to 3 psi.

[0699] Clause 262. The method of clauses 250-261, wherein the feature is configured to create and / or maintain one or more gaps by separating the lesion from an outer surface of the expandable structure adjacent the feature when the structure is in the expanded configuration.

[0700] Clause 263. The method of any one of clauses 250-262, comprising a plurality of features positioned in a configuration around the circumferential and / or axial length of the expandable structure to provide, create, or maintain the gap.

[0701] (Incorporated by reference) All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawings]

[0702] [Figure 1] 1A and 1B illustrate a scaffold having multiple stress-applying features distributed across its exterior surface in accordance with the principles of the present invention.

[0703] [Figure 2-1] 2A-2E illustrate different design and location examples for the stress application features of the present invention.

[0704] [Figure 2-2] 2F-1A-2F-3B illustrate additional configuration embodiments of the stress application features of the present invention.

[0705] [Figure 2-3] 2G-1A-2G-4B illustrate examples of placement of points, edges, and other sharp features on stress-applying features of the present invention.

[0706] [Figure 2-4] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention. [Figure 2-5] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention. [Figure 2-6] 2H-1-2H-22 illustrate various design embodiments for the stress application features of the present invention.

[0707] [Figure 3] FIG. 3 illustrates an expandable sleeve embodiment having a spiral pattern of stress-applying features on its outer surface.

[0708] [Figure 4] 4A and 4B illustrate a tubular scaffold or sleeve having a first array of stress-applying features on its outer surface.

[0709] [Figure 5] 5A and 5B illustrate a tubular scaffold or sleeve having a second array of stress-applying features on its outer surface.

[0710] [Figure 6]6A-6C illustrate a first method for folding unitary scaffolding elements into stress-applying features on the outer surface of the scaffold.

[0711] [Figure 7] 7A-7C illustrate a second method for folding unitary scaffolding elements into stress-applying features on the outer surface of the scaffold.

[0712] [Figure 8] 8A-8C illustrate a third method for folding unitary scaffolding elements into stress-applying features on the outer surface of the scaffold.

[0713] [Figure 9] 9A and 9B illustrate an example of how the stressing features of the present invention rupture calcified plaque when radially engaged against the plaque.

[0714] [Figure 10] 10A-10C illustrate an alternative embodiment of the present invention in which multiple stress-applying features are present on the exterior surface of an expandable structure, such as an inflatable angioplasty balloon or other medical balloon.

[0715] [Figure 11] 11A-11C illustrate an embodiment of the present invention having multiple stress-applying features similar to those illustrated in FIGS. 10A-10C, but arranged in yet another pattern.

[0716] [Figure 12-1] 12A-12C illustrate an embodiment of the present invention having multiple stress-applying features similar to those illustrated in FIGS. 10A-10C, but arranged in a different pattern, in accordance with the principles of the present invention.

[0717] [Figure 12-2] 12D-12H illustrate yet further variations of stressed feature patterns of the present invention. [Figure 12-3]12D-12H illustrate yet further variations of stressed feature patterns of the present invention.

[0718] [Figure 12H-1A] FIG. 12H-1A illustrates a first axial spacing pattern between circumferentially adjacent stress-applying features on the outer surface of an inflatable balloon.

[0719] [Figure 12H-1B] FIG. 12H-1B is a detailed view taken along line 1B-1B of FIG. 12H-1A.

[0720] [Figure 12H-2A] FIG. 12H-2A illustrates a second axial spacing pattern between circumferentially adjacent stress-applying features on the outer surface of an inflatable balloon.

[0721] [Figure 12H-2B] FIG. 12H-2B is a detailed view taken along line 2B-2B of FIG. 12H-2A.

[0722] [Figure 12H-3A] FIG. 12H-3A illustrates a third axial spacing pattern between circumferentially adjacent stress-applying features on the outer surface of an inflatable balloon.

[0723] [Figure 12H-3B] FIG. 12H-3B is a detailed view taken along line 3B-3B of FIG. 12H-3A.

[0724] [Figure 12-4] 12I-12L illustrate different balloon shapes and stress-induced feature distribution patterns in accordance with the principles of the present invention.

[0725] [Figure 13] 13A and 13B illustrate a tubular template that can be used in placing multiple stress-applying features on the exterior surface of a balloon or other expandable structure.

[0726] [Figure 14] 14A and 14B illustrate spherical stress-applying features mounted within a circular base (FIG. 14A) and a cylindrical base (FIG. 14B) present on the outer surface of an angioplasty balloon in accordance with the principles of the present invention.

[0727] [Figure 15] FIG. 15 illustrates exemplary perimeter dimensions for stress application features and / or support bases of the present invention.

[0728] [Figure 16-1] 16A-16H illustrate exemplary mounting methods for spherical, hemispherical, and other stress-applying features in accordance with the principles of the present invention.

[0729] [Figure 16-2] 16D-1-16D-6 illustrate exemplary attachment methods for spherical, conical, or other stress-applying features according to the principles of the present invention, where the features are attached within preformed depressions in the outer surface of a balloon or other expandable member, which provide a receptacle or "mounting" for securing the features using one or more adhesives or polymeric materials. FIG. 16D-1 is a perspective view. FIG. 16D-2 is a cross-sectional view of the balloon, and FIGS. 16D-3-16D-6 are detailed views of the features within the depressions taken along lines 1603-1603, 1604-1604, 1605-1605, and 1606-1606 in FIG. 16D-2, respectively. These embodiments are similar to those illustrated in FIG. 16D. [Figure 16-3]16D-1-16D-6 illustrate exemplary attachment methods for spherical, conical, or other stress-applying features according to the principles of the present invention, where the features are attached within preformed depressions in the outer surface of a balloon or other expandable member, which provide a receptacle or "mounting" for securing the features using one or more adhesives or polymeric materials. FIG. 16D-1 is a perspective view. FIG. 16D-2 is a cross-sectional view of the balloon, and FIGS. 16D-3-16D-6 are detailed views of the features within the depressions taken along lines 1603-1603, 1604-1604, 1605-1605, and 1606-1606 in FIG. 16D-2, respectively. These embodiments are similar to those illustrated in FIG. 16D.

[0730] [Figure 16-4] 16E-A-16E-G illustrate specific steps for encapsulating hemispherical features into depressions on the exterior surface of a stressed angioplasty balloon.

[0731] [Figure 16-5] 16E-1-16E-7 illustrate exemplary balloon indentation geometries conforming to stress application features shown in dashed lines, in accordance with the principles of the present invention.

[0732] [Figure 16-6] 16F-1-16F-4 illustrate exemplary stress application features having a base and a crown, where the base is secured within a recess in the balloon surface and the crown may protrude above the balloon surface, be flush with the balloon surface, or be recessed beneath the balloon surface.

[0733] [Figure 16-7] 16G-1-16G-12 illustrate exemplary techniques for mounting the base of a stress-applying feature of the present invention within a representative balloon recess geometry. [Figure 16-8]16G-1-16G-12 illustrate exemplary techniques for mounting the base of a stress-applying feature of the present invention within a representative balloon recess geometry. [Figure 16-9] 16G-1-16G-12 illustrate exemplary techniques for mounting the base of a stress-applying feature of the present invention within a representative balloon recess geometry.

[0734] [Figure 16-10] 16I-1-16I-3 illustrate an alternative exemplary technique for attaching the base of the stress-applying feature to the balloon surface by heat welding.

[0735] [Figure 17] 17A-17D illustrate spherical stressing features that are constrained or otherwise held onto the outer surface of the balloon using an elastic sleeve.

[0736] [Figure 18] 18A-18C illustrate the attachment of spherical stressing features onto the inner surface of an elastic sleeve and a method for expansion using an inflatable balloon.

[0737] [Figure 19] FIG. 19 illustrates stress-applying features present on the exterior surface of a drug delivery balloon catheter.

[0738] [Figure 20] 20A and 20B are cross-sectional views of the drug delivery balloon catheter of FIG. 19 shown in pre-inflation and post-inflation configurations, respectively, as used in drug delivery.

[0739] [Figure 21] 21A-21D illustrate alternative structures and methods for intravascular delivery of drugs using the plaque disruption features of the present invention. The structures of Figures 21C and 21D incorporate an elastic sleeve.

[0740] [Figure 22]FIG. 22 illustrates the stress application features of the present invention placed on the exterior of a balloon-expandable scaffold or "cage" of the type intended for temporary placement within a target vascular location for stress application and subsequent removal.

[0741] [Figure 23A] FIG. 23A shows placement of the expandable scaffold of FIG. 22 onto a balloon catheter prior to expansion of the balloon catheter.

[0742] [Figure 23B] FIG. 23B shows the expandable scaffold of FIG. 23A onto a balloon catheter following expansion of the balloon catheter.

[0743] [Figure 24] FIG. 24 is an end view of an expandable structure, such as a balloon catheter, having features, such as metal spheres, that contact and / or expand plaque tissue, showing the space created by the features, such as metal spheres, for fluid and / or contrast material to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque).

[0744] [Figure 24-1] 24A-24D are cross-sectional views of expandable structures, such as balloon catheters, having features, such as metal spheres, that contact and / or expand plaque tissue, with spaces created by the features, such as metal spheres, for fluid and / or contrast material to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque), showing different distribution patterns for the features. [Figure 24-2] 24A-24D are cross-sectional views of expandable structures, such as balloon catheters, having features, such as metal spheres, that contact and / or expand plaque tissue, with spaces created by the features, such as metal spheres, for fluid and / or contrast material to pass through between the outer surface of the expanded structure and the inner surface of the vessel (or plaque), showing different distribution patterns for the features.

[0745] [Figure 24-3] 24D-1-24D-3 illustrate features of the type illustrated in FIG. 24D having holes through the feature that further facilitate perfusion of contrast agent beyond the balloon when inflated within the vasculature. [Figure 24-4] 24D-1-24D-3 illustrate features of the type illustrated in FIG. 24D having holes through the feature that further facilitate perfusion of contrast agent beyond the balloon when inflated within the vasculature.

[0746] [Figure 25] FIG. 25 shows a conventional balloon angioplasty catheter within a simulated blood vessel (clear plastic tubing) that is perfused with a colored or contrast fluid, with flow blocked by an inflated balloon.

[0747] [Figure 26] FIG. 26 shows a simulated blood vessel perfused with a colored or contrast fluid, with flow bypassing the expanded balloon through a space created between the outer surface of the expanded balloon and the inner surface of the simulated vessel by a metal sphere or other feature.

[0748] [Figure 27] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 28] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 29]Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 30A] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 30B] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 31A] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 31B] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 31C]Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a multi-balloon design, with opposing surfaces with stress-applying features configured to capture cardiac or other valve leaflets and fracture calcification in a patient's valve. [Figure 31D] Figures 27, 28, 29, 30A, 30B, 31A-31F, 32, 33A-33D, 34, and 35A-35C illustrate different embodiments of catheters having a segmented balloon design or a mu...

Claims

1. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of stress-applying features distributed across at least a portion of an exterior surface of the expandable structure; Equipped with A device wherein the outer surface of the expandable structure has a plurality of preformed depressions, and at least some of the stress-applying features are supported and prevented from moving within individual depressions.

2. The device of claim 1 , wherein the expandable structure comprises an inflatable balloon.

3. The stress-applying features may have a density of 0.1 to 5 features / mm across at least a portion of the exterior surface of the expandable structure when the expandable structure is expanded. ２ , preferably 0.2 to 4 features / mm ２ , more preferably 0.25 to 3 features / mm ２ 3. The device according to claim 1, wherein the distribution density is in the range of

4. 4. The device of claims 1-3, wherein at least some of the stress-applying features have convex rounded apexes that protrude above the outer surface, the convex rounded apexes being configured to fracture the calcifications while minimizing damage to the body lumen when the expandable structure is expanded within the body lumen.

5. 5. The device of claim 4, wherein the convex rounded peaks of the stress-applying features have a radial height above the outer surface of the expandable structure within a range from a minimum of 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.5 mm, and 0.75 mm to a maximum of 1 mm, 0.5 mm, 0.4 mm, 0.3 mm, or 0.25 mm.

6. The apparatus of any one of claims 1 to 5, wherein at least some of the stress-applying features have upper surfaces that are flush with the outer surface.

7. 7. The device of claim 1, wherein at least some of the stress-applying features having upper surfaces flush with the exterior are secured within the recess by adhesive, an interference fit, encapsulation, ultrasonic welding, and / or combinations thereof.

8. The device of claims 1-7, wherein at least a portion of the outer surfaces of the expandable structure and the stress-applying features are free of any covering structure.

9. The device of claims 1-8, wherein an encapsulation layer covers at least a portion of the outer surface of the expandable structure and the stress-applying features and prevents the stress-applying features from moving on the outer surface of the expandable structure in a desired pattern.

10. A device according to any one of claims 1 to 8, wherein the depressions have an average width and / or depth ranging from 0.05 mm to 1 mm, preferably from 0.1 mm to 0.5 mm, more preferably from 0.1 mm to 0.25 mm.

11. The device of any one of claims 1 to 10, wherein the inflatable balloon comprises a stretchable wall.

12. The device of any one of claims 1 to 10, wherein the inflatable balloon comprises a non-extensible wall.

13. The device of claims 1-12, wherein at least some of the depressions in the balloon wall are configured to inhibit dimensional change as the balloon is inflated.

14. 14. The device of claim 13, wherein at least some of the depressions in the balloon wall are reinforced.

15. 13. The device of claim 1-12, wherein at least some of the depressions in the balloon wall are configured to constrict the constricted portion of the depression as the balloon is inflated to a nominal diameter.

16. The device of claims 1-15, wherein the depressions are staggered or patterned along the length and / or circumference of the balloon.

17. The device of claims 1-16, wherein the balloon has one or more of a cylindrical surface, a conical surface, and opposing surfaces, and the stress-applying features are disposed over some or all of these surfaces.

18. The device of claims 1-17, wherein the stress-applying feature is harder than the outer surface of the expandable structure.

19. The apparatus of any preceding claim, wherein the stress-applying feature comprises at least one of a metal, a polymer, or a ceramic material.

20. The device of claims 1-19, wherein the stress application feature is atraumatic, atraumatic with a coating, blunt, or blunt.

21. 21. The apparatus of claims 1-20, wherein the stress-applying features are roughened by sandblasting or other means to improve fracture, or to improve adhesion, or to improve encapsulation of the material.

22. The apparatus of any preceding claim, wherein the stress-applying feature comprises a magnet or a magnetizable material.

23. The apparatus of any preceding claim, wherein the stress-applying feature comprises one or more of a sphere, a hemisphere, a section of a sphere, a disk, a cylinder, and a cone.

24. 24. The apparatus of claim 1, wherein at least some of the stress-applying features have bases and crowns, and the bases of at least some of the stress-applying features are disposed within at least some of the plurality of pre-formed depressions.

25. 25. The apparatus of claim 24, wherein at least some of the stress-applying features comprise a core material encapsulated within a hardened material.

26. 26. The apparatus of claim 24 or 25, wherein at least a portion of the base of at least some of the stress-applying features is encapsulated within the hardened material.

27. 26. The device of claim 24 or 25, wherein at least a portion of the crowns of at least some of the stress-applying features are encapsulated within the hardened material.

28. 28. The apparatus of claims 24-27, wherein at least a portion of both the base and crown of at least some of the stress-applying features are encapsulated within the hardened material.

29. 29. The apparatus of claims 24-28, wherein the entire outer surfaces of at least some of the stress-applying features are encapsulated within the hardened material.

30. 30. The apparatus of claims 24-29, wherein the core material comprises at least one of a polymeric material and a ceramic material, and the hardened material comprises at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than the hardness of the core material.

31. 31. The device of claims 1-30, wherein the stress-applying features are partially or completely distributed across the surface of at least one section of the inflatable balloon selected from the group of sections selected from a central cylindrical section, a central concave section, a central narrow section, a flat end section, a tapered end section, and a conical end section.

32. 32. The device of claim 31, wherein at least one surface of at least one section of the inflatable balloon selected from the group of sections selected from a central cylindrical section, a central concave section, a central narrow section, a flat end section, a tapered end section, and a conical end section is free of stress-applying features distributed across the at least one surface.

33. 33. The device of claim 31 or 32, wherein the inflatable balloon comprises a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to expand over opposing surfaces of leaflets of a calcified valve to fracture calcification on the calcified valve.

34. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of stress-applying features distributed across an exterior surface of the expandable structure; an energy source within the interior of the expandable structure configured to deliver energy to the plaque disruption features to enhance plaque disruption; An apparatus comprising:

35. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of stress-applying features distributed across an outer surface of the expandable structure, at least some of the stress-applying features being harder than the outer surface of the expandable structure; An apparatus comprising:

36. 36. The apparatus of claim 35, wherein the stress-applying feature comprises at least one of a metal, a polymer, or a ceramic material.

37. 37. The device of claims 35 and 36, wherein the stress-applying feature is atraumatic, coated, blunt, or blunt.

38. 38. The apparatus of claims 35-37, wherein the stress-applying features are roughened by sandblasting or other means to improve one or more of fracture capability, surface adhesion, and encapsulation capability.

39. 39. The apparatus of claims 35-38, wherein the stress-applying feature comprises a magnet or magnetizable material.

40. 40. The apparatus of claims 35-39, wherein the stress-applying features are shaped as spheres, hemispheres, spherical segments, partial spheres, disks, cylinders, or cones.

41. 41. The apparatus of claims 35-40, wherein the stress-applying feature comprises a core covered by a hardened shell.

42. 1. An apparatus, comprising: a catheter including a catheter body having a proximal end and a distal section; a balloon having a surface with a plurality of preformed indentations formed over at least a portion thereof, the balloon being mounted on or relative to a distal section of the catheter body; a plurality of stress-applying features, each stress-applying feature having a base, a crown, and an outer surface, the bases of at least some of the stress-applying features being disposed within at least some of the plurality of pre-formed recesses; An apparatus comprising:

43. 43. The apparatus of claim 42, wherein at least some of the stress-applying features comprise a core material encapsulated within a hardened material.

44. 44. The apparatus of claim 43, wherein at least a portion of the bases of at least some of the stress-applying features are encapsulated within the hardened material.

45. 45. The apparatus of claims 43 and 44, wherein at least a portion of the crowns of at least some of the stress-applying features are encapsulated within the hardened material.

46. 46. ​​The apparatus of claims 43-45, wherein at least a portion of both the base and crown of at least some of the stress-applying features are encapsulated within the hardened material.

47. 47. The apparatus of claims 43-46, wherein the entire outer surfaces of at least some of the stress-applying features are encapsulated within the hardened material.

48. 48. The apparatus of claims 42-47, wherein the core material comprises at least one of a polymeric material and a ceramic material, and the hardened material comprises at least one of a metallic material, a polymeric material, and a ceramic material having a hardness greater than the hardness of the core material.

49. 1. A method comprising: providing a balloon having an outer surface; forming a plurality of depressions over at least a portion of an outer surface of the balloon; Dispensing a first adhesive into each of the depressions; placing stress-applying features within each of the depressions to cause a portion of the adhesive to be displaced onto the outer surface of the balloon surrounding each plaque disruption feature; coating each stress-applying feature with a spot layer of a second adhesive, the spot layer forming a seal with the first adhesive displaced onto the outer surface of the balloon surrounding each plaque disruption feature; A method comprising:

50. 50. The method of claim 49, wherein the first adhesive and the second adhesive comprise the same material.

51. 50. The method of claim 49, wherein the first adhesive and the second adhesive comprise different materials.

52. 52. The method of claims 49-51, further comprising at least one of: (a) coating at least a working length of the outer surface of the balloon with a base layer of an elastic polymer; and (2) forming a cover layer of an elastic polymer on at least the working length of the outer surface of the balloon.

53. 53. The method of claim 52, further comprising both (a) coating at least a working length of the outer surface of the balloon with a base layer of an elastic polymer, and (2) forming a cover layer of an elastic polymer on at least the working length of the outer surface of the balloon.

54. 54. The method of claim 52 or 53, wherein coating the outer surface of the balloon with a base layer of elastic polymer comprises coating the outer surface with a curable elastic adhesive and curing the elastic adhesive.

55. The method of any one of claims 49-54, wherein the elastic adhesive dispensed into the recess comprises a light-curable acrylic adhesive.

56. 56. The method of claim 55, wherein the spot layer comprises a light-curable acrylic adhesive.

57. 57. The method of claim 56, wherein the elastic adhesive dispensed into the depressions and the spot layer comprises chemically similar light-curable acrylic adhesives that fuse together when cured.

58. 1. An apparatus for treating a patient's valve having calcified leaflets, the apparatus comprising: a catheter body having a proximal end and a distal end; a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to deploy over opposing surfaces of the calcified valve leaflets and to fracture calcification on the calcified valve; features on one or both of the opposing inner walls configured to fracture calcified plaque on the valve leaflets as the opposing inner walls are deployed; An apparatus comprising:

59. 59. The device of claim 58, wherein the opposing inner walls are configured to approximate each other when the balloon structure is expanded.

60. 59. The device of claim 58, wherein the compartments are configured to be pulled together after the balloon structure is expanded and traps the calcified valve leaflets therebetween.

61. 61. Apparatus according to claims 58-60, wherein the feature comprises a plate.

62. 61. A device as described in claims 58-60, wherein the features comprise a protrusion on one of the opposing inner walls and a cavity on the other of the opposing inner walls, the protrusion configured to nest within the cavity when the opposing surfaces are deployed.

63. 1. An apparatus for treating a patient's valve having calcified leaflets, the apparatus comprising: a catheter body having a proximal end and a distal end; a compartmentalized structure disposed at the distal end of the catheter body, the compartmentalized structure having opposing inner walls configured to deploy on opposing surfaces of the valve leaflets and to fracture calcification on the calcified valve; Equipped with The device, wherein the opposing inner walls are configured to open to receive the valve leaflets and to close to capture the valve leaflets and apply stress to calcifications thereon.

64. 64. The device of claim 63, wherein the compartmentalized structure comprises two elements, each comprising one of the opposing interior walls, the elements configured to close together to capture and apply stress to the valve leaflets.

65. 65. The device of claim 64, wherein the element is expandable.

66. 65. The device of claim 64, wherein the element is non-expandable.

67. 67. The apparatus of claims 63-66, wherein at least one of the opposing interior walls comprises a stress-applying feature.

68. 1. An apparatus for treating a patient's valve having calcified leaflets, the apparatus comprising: a catheter body having a proximal end and a distal end; a segmented balloon structure disposed at the distal end of the catheter body, the segmented balloon structure having opposing inner walls configured to deploy on opposing surfaces of the valve leaflets and to fracture calcification on the calcified valve; Equipped with The device wherein two balloon sections are initially spaced apart on the catheter body, and the two balloon sections are configured to be spread apart such that the opposing inner walls converge and capture the calcified valve leaflets therebetween.

69. 1. A method for attaching stress-applying features to an exterior surface of a cylindrical support structure, the method comprising: providing a cylindrical carrier template having an outer surface; marking a pattern of attachment locations over at least a portion of an outer surface of the carrier template; affixing stress-applying features to an outer surface of the carrier template at at least some of the attachment locations; placing the carrier template over an outer surface of a cylindrical support structure; securing an inner surface of the carrier template to an outer surface of the support structure; A method comprising:

70. 70. The method of claim 69, wherein marking the pattern of attachment locations over at least a portion of the outer surface of the carrier template comprises forming depressions in the attachment locations.

71. 71. The method of claim 69 or 70, wherein affixing stress-applying features to an outer surface of the carrier template comprises dispensing adhesive therein at least some of the attachment locations.

72. 1. A device for treating a heart valve having calcified leaflets, the device comprising: a catheter body having a proximal end and a distal end; a balloon structure disposed at the distal end of the catheter body, the balloon structure having an outer surface configured to be deployed within the heart valve when the calcified valve leaflets are everted; and a sleeve configured to be positioned above the annulus of the heart valve and between the heart valve cusps and the wall of the aorta; Equipped with A device for treating a heart valve having calcified valve leaflets, wherein the balloon structure is configured to capture the valve leaflets between an outer surface of the balloon and an inner surface of the sleeve when the balloon is inflated.

73. 73. The device for treating a heart valve having calcified leaflets of claim 72, wherein at least one of an outer surface of the balloon and an inner surface of the sleeve comprises stress-applying features.

74. 74. The device for treating a heart valve having calcified leaflets of claim 73, wherein the outer surface of the balloon and the inner surface of the sleeve each comprise stress-applying features.

75. 75. A device for treating a heart valve having calcified leaflets as described in claims 72-74, further comprising an elongate deployment member on a distal end thereof carrying said sleeve.

76. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of needle-like stress-applying features distributed across at least a portion of an outer surface of the expandable structure; Equipped with At least a distal portion of at least some of the needle-like stress-applying features have an atraumatic covering over their distal tips.

77. 77. The apparatus of claim 76, wherein the expandable structure comprises an inflatable balloon.

78. 78. The device of claims 76 and 77, wherein at least some of the needle-like stress-applying features have sharp distal tips.

79. 79. The device of claim 78, wherein the atraumatic covering is compressible to expose the sharp distal tip when the covering is pressed against calcified plaque.

80. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal section; an expandable structure disposed in a distal section of the catheter body, the expandable structure having an outer surface configured to be displaced radially outward toward an inner surface of the body lumen wall; a plurality of elongated blade-like stress-applying features distributed across at least a portion of an outer surface of the expandable structure; Equipped with A device wherein at least some of said blade-like stress-applying features have a compressible atraumatic covering thereover.

81. 81. The apparatus of claim 80, wherein the expandable structure comprises an inflatable balloon.

82. 82. The device of claims 80 and 81, wherein the atraumatic covering covers the entire blade-stressing feature, including the sharp edge, prior to the covering being compressed.

83. 83. The device of claim 82, wherein the sharp edges are exposed across a surface of the atraumatic covering prior to the covering being compressed.

84. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon having a balloon wall comprised of a single polymer layer and an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall when the balloon is inflated; a plurality of rigid stress-applying features distributed across at least a portion of an outer surface of the expandable polymeric balloon, each of the rigid stress-applying features having a base adhered directly to the outer surface of the single polymer layer by one or more layers of adhesive polymer having a compliance equal to or greater than that of the single polymer layer; An apparatus comprising:

85. 85. The device of claim 84, wherein the single polymer layer of the balloon has a compliance in the range of 0% to 25%, 1% to 25%, preferably 5% to 20%, more preferably 5% to 15%.

86. 86. Apparatus according to claims 84 and 85, wherein the adhesive polymer has a compliance in the range of 1% to 30%, 2% to 30%, preferably 5% to 25%, more preferably 5% to 20%.

87. The device of claims 84-86, wherein the single polymer layer has a uniform wall thickness across at least a portion of the balloon wall.

88. 88. The device of claim 87, wherein the balloon wall thickness varies by no more than ±20%, typically no more than ±10%, over at least the cylindrical wall portion.

89. The device of claims 84-88, further comprising a base layer of polymer adhesive directly below the bottom of the rigid stress application feature, the base layer having a compliance equal to or greater than the compliance of the single polymer layer formed across the outer balloon surface.

90. The device of claims 84-89, further comprising multiple spot layers of polymer adhesive between the outer surface of the balloon and the bottom of the rigid stress application feature, the layer having compliance equal to or greater than the compliance of the single polymer layer.

91. 91. The apparatus of claim 90, comprising both a base layer of the polymer adhesive and a plurality of spotted layers of the polymer adhesive.

92. 92. The apparatus of claim 91, wherein the base layer of polymer adhesive and the plurality of spotted layers of polymer adhesive comprise the same polymer adhesive.

93. 92. The apparatus of claim 91, wherein the base layer of polymer adhesive and the plurality of spot layers of polymer adhesive comprise different polymer adhesives.

94. The device of claims 84-93, further comprising an upper layer of polymer adhesive having a compliance equal to or greater than the compliance of the single polymer layer formed over both the rigid stress application feature and at least a portion of the outer balloon surface of the rigid stress application feature.

95. 95. The device of claim 94, wherein the top layer of polymer adhesive has a compliance in the range of 1% to 30%, 2% to 30%, preferably 5% to 25%, more preferably 5% to 20%.

96. 96. The device of claims 94 and 95, wherein the multiple spotted overlayers of polymer adhesive cover the rigid stress applying features and areas of the outer balloon surface peripherally adjacent the base of the rigid stress applying features.

97. 96. The device of claims 94 and 95, wherein the continuous top layer of polymer adhesive covers all rigid stress-applying features and at least a portion of the outer balloon surface.

98. 98. The device of claim 97, wherein the continuous top layer of polymer adhesive covers the entire outer balloon surface.

99. 98. The apparatus of claim 97, comprising both a spotted overlayer of polymer adhesive and a continuous overlayer of polymer adhesive, the continuous overlayer covering the spotted overlayer.

100. 100. The apparatus of claim 99, wherein the continuous overlayer of polymer adhesive and the multiple spotted overlayers of polymer adhesive comprise the same polymer adhesive.

101. 100. The apparatus of claim 99, wherein the base layer of polymer adhesive and the plurality of spot layers of polymer adhesive comprise different polymer adhesives.

102. The apparatus of any one of claims 84-101, wherein the rigid stress-applying feature comprises a metal.

103. The device of claims 84-102, wherein the rigid stress-applying feature has a convex, rounded upper surface configured to fracture the calcifications when the expandable structure is expanded within the body lumen.

104. 104. The apparatus of claim 103, wherein the rigid stress-applying feature is shaped as a sphere, a hemisphere, a spherical segment, a partial sphere, a disk, a cylinder, or a cone.

105. 105. The device of claims 103 and 104, wherein the rigid stress-applying feature has a flat or contoured bottom that is adhesively bonded to the outer balloon surface.

106. The device of any one of claims 84-105, wherein the rigid stress-applying feature is disposed within a depression formed in the outer surface of the balloon.

107. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon comprising a polymer balloon wall having a hardness; a plurality of rigid stress-applying features distributed across at least a portion of an outer surface of the polymeric balloon wall, the rigid stress-applying features having a hardness greater than a hardness of the expandable polymeric balloon and having a base attached directly to the outer surface of the polymeric layer by one or more layers of one or more adhesive polymers, the adhesive polymers having a hardness when cured that is equal to or less than a hardness of the balloon; An apparatus comprising:

108. 108. The device of claim 107, wherein the adhesive polymer(s) when cured have a hardness that is less than the hardness of the balloon.

109. 109. The apparatus of claim 108, wherein the inflatable balloon has a Shore hardness in the range of 60D to 80D, the polymer adhesive(s) when cured have a Shore hardness in the range of 50D to 65D, and the rigid stress application feature has a Mohs hardness greater than 4, preferably greater than 8.

110. 110. The apparatus of claims 107-109, wherein one of the layers is a spot adhesive over a first adhesive polymer layer and under the stress application feature.

111. The device of claims 107-110, wherein two adhesive polymer layers are on the outer surface of the balloon and spot adhesives attach the stress-applying features.

112. The device of any one of claims 107-111, wherein the spot adhesive has a hardness less than that of the balloon but greater than that of either of the two adhesive layers.

113. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon having a polymer balloon wall comprised of a single polymer layer having a wall thickness; a polymeric underlayer formed over an outer surface of the inflatable polymeric balloon; a plurality of rigid stress-applying features distributed across at least a portion of an outer surface of the polymeric substrate; An apparatus comprising:

114. 114. The device of claim 113, wherein the polymer base layer covers at least the working length of the outer surface of the inflatable polymer balloon.

115. 115. The device of claim 114, wherein the polymer base layer covers the entire outer surface of the inflatable polymer balloon.

116. 114. The device of claim 113, wherein the polymer base layer comprises axial strips across the balloon surface.

117. 114. The device of claim 113, wherein the polymer base layer comprises circumferential strips across the balloon surface.

118. The device of any one of claims 113-117, wherein the polymer base layer has a hardness less than the hardness of the inflatable polymer balloon.

119. The device of any one of claims 113-117, wherein the polymer base layer has a hardness greater than the hardness of the inflatable polymer balloon.

120. 120. The device of claims 113-119, further comprising a polymer cover layer formed over both the plurality of rigid stress-applying features and the polymer base layer, the polymer base layer having a thickness no greater than 50% of a wall thickness of the inflatable polymer balloon.

121. The device of any one of claims 113-120, wherein the polymer balloon wall has a Shore D hardness in the range of 60D to 80D and the polymer base layer has a Shore D hardness in the range of 50D to 65D.

122. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon having a polymer balloon wall comprised of a single polymer layer having a wall thickness; a plurality of rigid stress-applying features distributed across at least a portion of an exterior surface of the polymeric balloon wall; a polymer cover layer formed over both the plurality of rigid stress-applying features and an outer surface of the polymeric balloon wall; An apparatus comprising:

123. 123. The device of claim 122, wherein the polymer cover layer has a thickness that is no greater than 50% of the wall thickness of the expandable polymer balloon.

124. 124. The device of claim 122 or 123, wherein the polymer cover layer covers at least the working length of the outer surface of the inflatable polymer balloon.

125. 125. The device of claim 124, wherein the polymer cover layer covers the entire outer surface of the inflatable polymer balloon.

126. 123. The device of claim 122, wherein the polymer cover layer comprises axial strips across the balloon surface.

127. 123. The device of claim 122, wherein the polymer cover layer comprises circumferential strips across the balloon surface.

128. The device of any one of claims 122-127, wherein the polymer cover layer has a hardness less than the hardness of the inflatable polymer balloon.

129. The device of any one of claims 122-127, wherein the polymer cover layer has a hardness greater than the hardness of the inflatable polymer balloon.

130. The device described in claims 122-129, further comprising a polymer base layer formed over the outer surface of the expandable polymer balloon and beneath at least some of the plurality of rigid stress-applying features, the polymer base layer having a thickness that is 50% or less of the wall thickness of the expandable polymer balloon.

131. The device of claims 122-130, wherein the polymer balloon wall has a Shore D hardness in the range of 60D to 80D and the polymer cover layer has a Shore D hardness in the range of 50D to 65D.

132. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a hardness and an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall; a plurality of discrete stress-applying features, each of the plurality of discrete stress-applying features having a hardness, a base, and a rounded convex upper surface, the discrete stress-applying features being dispersed across at least a portion of the outer surface; at least a first polymer adhesive layer disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon; An apparatus comprising:

133. 133. The device of claim 132, wherein the first polymeric adhesive layer comprises a base layer configured to cover a continuous surface area of ​​the outer balloon surface, the continuous surface area being large enough to underlie at least a majority of the plurality of discrete stress-applying features distributed across the continuous surface area in both the axial and circumferential directions.

134. 134. The apparatus of claim 133, wherein the continuous surface area is large enough to lie beneath at least a majority of the plurality of discrete stress-applying features.

135. 135. The apparatus of claim 134, wherein the continuous surface area is large enough to be beneath all of the plurality of discrete stress-applying features.

136. The device of any one of claims 133-135, wherein the first adhesive layer is softer than the polymer balloon.

137. The device of claims 133-136, wherein the continuous surface area includes at least a cylindrical area of ​​the outer surface of the balloon.

138. The device of claims 133-137, wherein the continuous surface region comprises at least a portion of a tapered or conical end region of the outer surface of the balloon.

139. The device of claims 133-136, wherein the continuous surface region comprises at least one spiral strip disposed across a cylindrical region and / or a tapered or conical region of the balloon.

140. The device of claims 133-136, wherein the continuous surface region comprises at least one axial strip disposed across a cylindrical region and / or a tapered or conical region of the balloon.

141. The device of claims 133-136, wherein the continuous surface region comprises at least one circumferential band disposed across a cylindrical region and / or a tapered or conical region of the balloon.

142. An apparatus according to any one of claims 133 to 136, wherein the continuous surface area comprises a random two-dimensional pattern.

143. The device of claims 133-136, wherein the continuous surface of the balloon comprises a cylindrical surface and the plurality of discrete stress-applying features are arranged in a number of circumferentially adjacent bands axially spaced along the cylindrical surface.

144. The device of any one of claims 133-143, further comprising at least a second polymer adhesive layer disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon.

145. 145. The device of claim 144, wherein the first polymeric adhesive layer and the second polymeric adhesive layer both cover the same continuous surface area of ​​the outer balloon surface.

146. 145. The device of claim 144, wherein the first polymer adhesive layer and the second polymer adhesive layer each cover a different continuous surface area of ​​the outer balloon surface.

147. The device of any one of claims 144-146, wherein the first polymer adhesive layer and the second polymer adhesive layer each have a thickness that is less than or equal to 50% of the wall thickness of the expandable polymer balloon.

148. 145. The device of claim 144, wherein the second adhesive layer comprises a plurality of adhesive spots.

149. 149. The device of claim 148, wherein each adhesive spot is located directly beneath an individual discrete stress application feature and across the outer surface of the balloon.

150. 150. The device of claims 148 and 149, wherein the adhesive spots are present across the first polymer adhesive layer and beneath the discrete stress-applying features.

151. 150. The device of claims 148 and 149, wherein the adhesive spots are located underneath both the first polymer adhesive layer and the discrete stress-applying features and across the outer surface of the balloon.

152. 152. The apparatus of claims 144-151, wherein the first polymer adhesive layer and the second polymer adhesive layer comprise the same adhesive polymer material.

153. 152. The apparatus of claims 144-151, wherein the first polymer adhesive layer and the second polymer adhesive layer comprise different adhesive polymer materials.

154. The device of claims 144-153, wherein the adhesive layer attached directly to the outer surface of the balloon is softer than the adhesive layer attached directly to the bottom of the stress-applying feature.

155. 154. An apparatus according to any one of claims 144-153, wherein the first polymeric adhesive layer and / or the second polymeric adhesive layer comprise one or more adhesive materials.

156. The device of any of claims 133-155, further comprising a first polymer cover layer.

157. 157. The device of claim 156, wherein the first polymer cover layer covers the outer surface of the balloon.

158. 158. The device of claims 156 and 157, wherein the first polymer cover layer covers at least some of the plurality of discrete stress-applying features.

159. The apparatus of any one of claims 156-158, wherein the first polymer cover layer covers at least some of the first polymer adhesive layer.

160. 160. The apparatus of claims 156-159, wherein the first polymer cover layer covers at least some of the first polymer adhesive layer.

161. The apparatus of any one of claims 156-160, wherein the first polymer cover layer comprises a polymer adhesive.

162. The device described in claims 156-161, wherein the first polymer adhesive layer, when cured, has a hardness that is less than the hardness of the wall of the expandable polymer balloon and less than the hardness of the discrete stress-applying features, and the first polymer adhesive is configured to accommodate differential expansion between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated.

163. 163. The device of claim 162, wherein the discrete stress-applying features have a Mohs hardness of at least 4, the polymer balloon wall has a Shore hardness in the range of 60D to 90D, and the first polymer adhesive has a Shore hardness in the range of 50D to 70D.

164. 164. The apparatus of claims 162 and 163, wherein the discrete stress-applying features comprise at least one of a metal, a metal alloy, a mineral, a ceramic, and a hardened polymer.

165. 165. The apparatus of claim 164, wherein the discrete stress-applying features comprise a metal or metal alloy comprising at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

166. The device of claims 162-165, wherein the polymer balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

167. 167. The device of claims 132-166, wherein any one or more of the first polymeric adhesive layer, the second polymeric adhesive layer, and the first polymeric cover layer comprise at least one of polymethacrylate, polyurethane-methacrylate, polyisobornyl acrylate, acrylic urethane methacrylate, methacrylate ester acrylic, modified methacrylate ester, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene vinyl acetate, polyethylene methyl acrylate, polyethylene, acrylic, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea-formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic glue, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, or combinations thereof.

168. The device described in claims 132-167, further comprising at least a second polymer adhesive layer disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon, the at least second polymer adhesive layer, when cured, having a hardness greater than or equal to the hardness of the first polymer adhesive layer, which typically has a Shore hardness in the range of 50D to 70D.

169. 169. The device of claim 168, wherein the first polymer adhesive layer and the second polymer adhesive layer have the same hardness.

170. 169. The device of claim 168, wherein the first polymer adhesive layer and the second polymer adhesive layer have different hardnesses.

171. The apparatus of any one of claims 168-170, wherein the second polymer adhesive comprises a spot adhesive.

172. 172. The device of claim 171, wherein the spot adhesive is formed across the first polymer adhesive layer.

173. 172. The device of claim 171, wherein the spot adhesive is formed under the first polymer adhesive layer.

174. 174. The device of claim 173, wherein the first polymer cover layer has a Shore hardness in the range of 50D to 70D.

175. The device of claims 156-174, further comprising a second polymer cover layer formed over the outer surface of the balloon and covering the plurality of discrete stress-applying features.

176. 176. The device of claim 175, wherein the second polymer cover layer comprises a polymer adhesive.

177. The device of claims 175 and 176, wherein the first polymer cover layer and the second polymer cover layer each have a thickness that is no greater than 50% of the wall thickness of the expandable polymer balloon.

178. The apparatus of any one of claims 175-177, wherein the second polymer cover layer has a Shore hardness in the range of 50D to 70D.

179. The device of claims 132-178, wherein the balloon wall consists of a single layer of polymeric material.

180. The device of claims 132-179, wherein the balloon wall is made of a single material having a hardness ranging from 55D to 90D.

181. 181. The device of claims 179 and 180, wherein the polymeric material comprises a homogeneous polymeric composition.

182. An apparatus as described in claims 132-181, wherein at least some of the plurality of discrete stress-applying features are formed as monolithic structures.

183. An apparatus as described in claims 132-181, wherein at least some of the plurality of discrete stress-applying features are formed as polylithic structures.

184. 184. The apparatus of claims 175-183, wherein at least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer cover layer, and the second polymer adhesive cover layer comprises a homogenous polymer material.

185. 184. The device of claim 175-183, wherein at least one of the first polymer adhesive layer, the second polymer adhesive layer, the first polymer cover layer, and the second polymer adhesive cover layer comprises a reinforcement, a filler, a crosslinker, or an additive.

186. The device of claims 144-185, wherein the first polymer adhesive layer and / or the second polymer adhesive layer attach the bottom of the discrete stress-applying features to the outer surface of the inflatable polymer balloon.

187. 186. The device of claims 175-185, wherein the first polymeric adhesive layer, the second polymeric adhesive layer, the first polymeric adhesive cover, and / or the second polymeric adhesive cover each comprise at least one polymer selected from the group consisting of polymethacrylate, polyurethane-methacrylate, polyisobornyl acrylate, acrylic urethane methacrylate, methacrylate ester acrylic, modified methacrylate ester, polyester, epoxy adhesive, phenolic adhesive, polyvinyl acetate, polyethylene vinyl acetate, polyethylene methyl acrylate, polyethylene, acrylic, cyanoacrylate, hybrid cyanoacrylate / epoxy adhesive, urea-formaldehyde, polyimide, natural or synthetic rubber modified with tackifying resin, styrene-butadiene rubber latex, silicone rubber, anaerobic glue, mussel adhesive protein, polydopamine-clay-polyacrylamide, Caulobacter crescentus, Delo Monopox, and combinations thereof.

188. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a hardness and an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall; a plurality of discrete stress-applying features, each of the plurality of discrete stress-applying features having a hardness, a base, and a rounded convex upper surface, the discrete stress-applying features being dispersed across at least a portion of the outer surface; a polymer layer disposed between the bottom of the discrete stress-applying features and the outer surface of the inflatable polymeric balloon, the polymer layer covering a continuous surface area of ​​the outer balloon surface and being large enough to be underneath at least a majority of the plurality of discrete stress-applying features distributed across the continuous surface area in both the axial and circumferential directions; a plurality of adhesive spots deposited across the polymer layer to enhance attachment of a bottom of each of the plurality of discrete stress-applying features to the polymer layer; An apparatus comprising:

189. The device of claim 188, wherein the polymer layer is softer than the polymer balloon.

190. The device of claim 188, wherein the adhesive spot is softer than the polymer balloon.

191. The device of claims 188-190, wherein the polymer layer is configured to both (a) adhere to the outer balloon surface and (b) accommodate differential expansion between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated.

192. The device described in claims 188-191, wherein the plurality of adhesive spots are configured to both (a) adhere to the polymer layer and attach the stress-applying features to the outer balloon surface, and (b) further accommodate differential expansion between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated.

193. 193. The apparatus of claims 188-192, wherein the plurality of stress-applying features are distributed across the continuous surface area in both axial and circumferential directions.

194. 194. The apparatus of claim 193, wherein the plurality of stress-applying features are arranged across the continuous surface area in one or more axial strips, one or more circumferential bands, or two or more spiral lines.

195. 194. The apparatus of claim 193, wherein the plurality of stress-applying features are arranged across the continuous surface area in two or more axial strips, two or more circumferential bands, or one or more spiral lines.

196. 194. The apparatus of claim 193, wherein the plurality of stress-applying features are arranged across the continuous surface area in a random two-dimensional grid.

197. 197. The apparatus of any one of claims 188-196, wherein the continuous surface area is sufficiently large to lie beneath at least a majority of the plurality of discrete stress-applying features.

198. 197. The apparatus of any one of claims 188-196, wherein the continuous surface area is large enough to be beneath all of the plurality of discrete stress-applying features.

199. The device of claims 188-198, wherein the polymer layer is inseparable from the outer surface of the balloon.

200. The device of claims 188-199, wherein the polymer layer is adhered to the outer surface of the balloon by one or more of heat, fusion, welding, deposition, gluing, and the use of adhesives.

201. The apparatus of any one of claims 188-200, wherein the polymer layer comprises a polymer adhesive material.

202. 202. The device of claim 201, wherein the polymer layer consists of, or consists essentially of, a polymer adhesive material.

203. 202. The device of claim 201, wherein the polymer layer comprises a combination of adhesive and non-adhesive polymer materials.

204. The apparatus of any one of claims 188-203, wherein the adhesive spots comprise an adhesive polymer material.

205. An apparatus as described in claims 188-203, wherein the adhesive spots consist of or consist essentially of a polymer adhesive material.

206. The apparatus of claims 188-203, wherein the adhesive spots comprise a combination of polymer adhesive material and non-adhesive polymer material.

207. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a hardness and an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall; a plurality of discrete stress-applying features, each of the plurality of discrete stress-applying features having a hardness, a base, and a rounded convex upper surface, the discrete stress-applying features being dispersed across at least a portion of the outer surface; a first polymer layer disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymeric balloon, the first polymer layer covering a continuous surface area of ​​the outer balloon surface and being large enough to be underneath at least a majority of the plurality of discrete stress-applying features distributed across the continuous surface area in both the axial and circumferential directions; a plurality of second polymeric materials encapsulating at least a bottom portion of each of the plurality of stress-applying features and attached to the first polymeric layer; An apparatus comprising:

208. 208. The apparatus of claim 207, wherein the second polymeric material is attached to the first polymeric material by one or more of heat, adhesive, fusing, soldering, or a combination.

209. 209. The device of claims 207 and 208, wherein the first polymeric material and the second polymeric material are the same material.

210. 209. The device of claims 207 and 208, wherein the first polymeric material and the second polymeric material are different materials.

211. The device of claims 207-210, wherein the first polymeric material is softer than the polymeric balloon.

212. The device of any one of claims 207-211, wherein the second polymeric material is softer than the polymeric balloon and harder than the first polymeric material.

213. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to the distal end of the catheter body, the expandable polymer balloon having a hardness and an outer surface configured to be displaced radially outward toward the inner surface of the body lumen wall; a plurality of discrete stress-applying features, each of the plurality of discrete stress-applying features having a hardness, a base, and a rounded convex upper surface, the discrete stress-applying features being dispersed across at least a portion of the outer surface; a plurality of discrete polymer adhesive spots formed as at least one layer and disposed between the bottom of the discrete stress-applying features and the outer surface of the expandable polymer balloon; at least a first polymer adhesive layer disposed over an exterior surface of the inflatable polymer balloon overlapping at least a portion of at least one layer of the plurality of discrete polymer adhesive spots; Equipped with The device, wherein the discrete polymer adhesive spots and first polymer adhesive layer are configured to accommodate differential expansion between the bottoms of the discrete stress-applying features and the outer surface of the expandable polymer balloon as the balloon is inflated.

214. 214. The apparatus of claim 213, wherein the plurality of discrete adhesive spots extend beyond the periphery of the bottom of the plurality of stress-applying features.

215. 215. The apparatus of claims 213 and 214, wherein the first polymer adhesive layer covers at least one layer of the plurality of discrete polymer adhesive spots.

216. The apparatus of any one of claims 213-215, wherein the first polymer adhesive layer covers at least a portion of the plurality of discrete stress-applying feature surfaces.

217. The apparatus of claims 213-216, wherein the plurality of discrete adhesive spots and the first polymer adhesive layer are the same polymer adhesive.

218. The apparatus of any one of claims 213-216, wherein the plurality of discrete adhesive spots and the first polymer adhesive layer are different polymer adhesives.

219. An apparatus as described in claims 213-218, wherein at least a first polymer adhesive cover layer covers at least a portion of the plurality of discrete stress-applying feature surfaces.

220. The apparatus of claims 213-219, wherein the first polymer adhesive cover layer covers at least a portion of the first polymer adhesive layer.

221. The apparatus of any one of claims 213-220, wherein at least a first polymer adhesive cover layer covers at least a portion of the plurality of discrete stress-applying feature surfaces and at least a portion of the first polymer adhesive layer.

222. 221. The apparatus of claims 213-220, wherein the first polymer adhesive cover layer covers all of the plurality of discrete stress-applying feature surfaces and all of the first polymer adhesive layer.

223. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body and having an outer balloon surface; a plurality of discrete rigid stress-applying features attached to the outer balloon surface; Equipped with the discrete rigid stress-applying features are arranged in a first plurality of circumferential bands on the outer surface of the polymeric balloon; A device wherein each stress-applying feature within a circumferential band is axially offset from at least one circumferentially adjacent stress-applying feature within the same band when the polymeric balloon is inflated.

224. The device of claim 223, wherein the plurality of discrete rigid stress-applying features are further arranged in a second plurality of axially oriented strips disposed along the length of the outer surface of the balloon.

225. The device of claim 224, wherein the stress-applying features in some or all of the axially oriented strips are axially offset from the stress-applying features in circumferentially adjacent axially oriented strips when the balloon is inflated.

226. 226. The apparatus of claims 224 and 225, wherein the stress-applying features on at least some of the axially oriented strips have the same axial spacing.

227. 226. The apparatus of claims 224 and 225, wherein the stress-applying features in all axially oriented strips have the same axial spacing.

228. The device of claims 223-227, wherein at least some of the stress-applying features within at least some circumferential bands are axially offset from other of the stress-applying features within those circumferential bands when the balloon is deflated, to improve the crush force per stress-applying feature and / or avoid stacking of the stress-applying features.

229. 229. The apparatus of claim 228, wherein all of the stress-applying features in at least some circumferential bands are axially offset from others of the stress-applying features in the circumferential bands.

230. 229. The apparatus of claim 228, wherein all of the stress-applying features in each circumferential band are axially offset from other of the stress-applying features in that circumferential band.

231. An apparatus as described in claims 223-230, wherein all of the stress-applying features within the same circumferential band have the same circumferential spacing therebetween.

232. An apparatus as described in claims 223-231, wherein the stress-applying features in at least some circumferential bands have the same circumferential spacing therebetween.

233. An apparatus as described in claims 223-232, wherein at least some of the stress-applying features have convex rounded upper surfaces and rounded bases surrounding a center.

234. Apparatus according to any one of claims 223 to 233, wherein the stress-applying features have a width or diameter in the range 0.15mm to 1mm, preferably 0.2mm to 1mm, typically 0.3mm to 0.6mm.

235. Apparatus according to any one of claims 223 to 234, wherein the stress applying features are axially offset by a distance in the range of 0.3mm to 2mm, preferably 0.4mm to 1.5mm, typically 0.5mm to 1mm.

236. 236. An apparatus as described in claims 223-235, wherein circumferentially adjacent stressing features are sufficiently axially spaced apart so that the peripheral edges of said circumferentially adjacent stressing features do not overlap axially, and the peripheral edges of said circumferentially adjacent stressing features have a gap therebetween in the range of 0 to 3 mm, typically 0 to 2 mm, preferably 0.05 mm to 0.4 mm.

237. The device of claims 223-236, wherein all stress-applying features are sufficiently spaced apart so that when the expandable polymer balloon is deflated, the peripheral edges of the stress-applying features do not axially overlap and have a gap between them in the range of 0 to 3 mm, typically 0 to 2 mm, and preferably 0.05 mm to 0.4 mm.

238. The device of claim 237, wherein the width or diameter of each stress application feature, the axial offset between circumferentially adjacent stress application features, and the circumferential offset between axially adjacent stress application features are constant for all stress application features when the expandable polymer balloon is inflated.

239. An apparatus as described in claims 223-238, wherein the center of the stress-applying feature comprises the center of a bottom surface of the stress-applying feature.

240. An apparatus as described in claims 223-239, wherein the center of the stress-applying feature comprises the center of an upper surface of the stress-applying feature.

241. The apparatus of claims 238-240, wherein the axial and circumferential offsets are measured relative to the centers of the adjacent stress-applying features.

242. 242. The device of claims 223-241, wherein the density of the circumferential bands along the axial length ranges from 0.2 strips / mm of axial balloon length to 2 strips / mm of axial balloon length, preferably from 0.3 strips / mm of axial balloon length to 1 strip / mm of axial balloon length, and most preferably from 0.4 strips / mm of axial balloon length to 1 strip / mm of axial balloon length.

243. An apparatus as described in claims 223-242, wherein the bottoms of axially adjacent stress-applying features in at least some of the axially oriented strips are axially spaced apart by a distance ranging from 0.5 mm to 3 mm, typically ranging from 1 mm to 2.5 mm, preferably ranging from 1.5 mm to 2.5 mm.

244. An apparatus as described in claims 223-243, wherein at least some of the discrete stress-applying features are formed as spheres, hemispheres, partial spheres, ellipsoids, or other shapes having convex, rounded upper surfaces.

245. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body and having an outer balloon surface; a plurality of rigid stress-applying features attached to the outer balloon surface; Equipped with at least some of the stress-applying features have a convex rounded upper surface and a base attached directly or indirectly to the balloon surface; the peripheral edges of the stressing features do not overlap when the balloon is deflated; Device.

246. The device of claim 245, wherein the peripheral edges of adjacent stress-applying features have a gap between them in the range of 0 to 3 mm, typically 0 to 2 mm, preferably 0.05 mm to 0.4 mm when the polymer balloon is deflated.

247. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to a distal end of the catheter body, the expandable polymer balloon having an outer surface; a plurality of stress-applying features attached to an outer surface of the inflatable balloon; Equipped with The stress-applying features may have a density of 0.1 to 5 features / mm across at least an expanded region of the expandable polymer balloon when the expandable polymer balloon is fully inflated. ２ , preferably 0.2 to 4 features / mm ２ , more preferably 0.25 to 3 features / mm ２ The device has a distribution density in the range of

248. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to a distal end of the catheter body, the expandable polymer balloon having an outer surface; a plurality of stress-applying features attached to an outer surface of the expandable polymer balloon; Equipped with The stress-applying features may have a density of 0.1 to 5 features / mm across at least an expanded region of the expandable polymer balloon when the expandable polymer balloon is fully inflated. ２ , preferably 0.2 to 4 features / mm ２ , more preferably 0.25 to 3 features / mm ２ The device has a distribution density in the range of

249. The device of claim 248, wherein the expanded region of the inflatable polymer balloon comprises the entire expandable surface area of ​​the balloon.

250. The device of claim 248, wherein the expanded region of the inflatable polymer balloon comprises the central region of the balloon excluding the tapered end regions of the balloon.

251. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an expandable polymer balloon attached to a distal end of the catheter body, the expandable polymer balloon having an outer surface; a plurality of stress-applying features attached to an exterior surface of the polymer balloon; Equipped with the stress-applying features each have a base region in contact with the exterior surface of the expandable polymer balloon; The ratio of (1) the cumulative area of ​​all base regions in contact with the outer surface of the expandable polymer balloon to (2) the total area of ​​the outer surface of the expandable polymer balloon is in the range of 1:100 to 5:100, typically 2:100 to 5:100, and preferably 3:100 to 4:

100.

252. 252. The device of claim 251, wherein the outer surface of the expandable polymer balloon comprises the entire expandable surface area of ​​the balloon.

253. 252. The device of claim 251, wherein the outer surface of the expandable polymer balloon comprises a central region of the balloon excluding tapered end regions of the balloon.

254. The device of claims 251-253, wherein the stress-applying feature has a convex rounded upper surface and a rounded base region that contacts the outer balloon surface.

255. The apparatus of claims 251-254, wherein the stress-applying features all have the same dimensions.

256. The device described in claims 251-255, wherein the stress-applying features are uniformly distributed across the outer surface of the expandable polymer balloon.

257. 1. An apparatus for treating calcifications on a wall in a body lumen of a patient, the apparatus comprising: a catheter including a catheter body having a proximal end and a distal end; an inflatable polymer balloon attached to the distal end of the catheter body, the inflatable polymer balloon having an outer surface with a central region, a tapered distal region, a tapered proximal region, a distal transition region between the distal tapered region and the central region, and a proximal transition region between the proximal tapered region and the central region; a plurality of rigidity features attached to the outer surface of the expandable polymeric balloon, at least some of the rigidity features being distributed across at least a portion of one of: (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, (d) the proximal tapered region, (e) a 2 mm length of the distal end of the central region, and (f) a 2 mm length of the proximal end of the central region of the outer surface of the expandable polymeric balloon; An apparatus comprising:

258. 258. The device of claim 257, wherein at least some of the rigidity features have convex, rounded upper surfaces.

259. 259. Apparatus according to claims 257 and 258, wherein the rigidity features have a width or diameter in the range of 0.15mm to 1mm, preferably 0.2mm to 1mm, typically 0.3mm to 0.6mm.

260. 260. The apparatus of claims 257-259, wherein the discrete rigidity features comprise a metal or metal alloy comprising at least one of iron, platinum, cobalt, chromium, rhodium, titanium, tungsten, and nickel.

261. The device of claims 257-260, wherein the expandable polymer balloon comprises a semi-compliant balloon having a nominal inflation pressure and a rated burst pressure, and wherein the diameter of a central region of the balloon increases by a percentage in the range of 1% to 20%, typically 5% to 20%, and preferably 5% to 15% as the balloon is inflated from its nominal inflation pressure to its rated burst pressure.

262. 262. The device of claim 261, wherein the polymer balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

263. The device of claims 257-262, wherein the expandable polymer balloon comprises a non-compliant balloon having a nominal inflation pressure and a rated burst pressure, and wherein the diameter of a central region of the balloon increases by a percentage less than or equal to 20%, preferably less than or equal to 15%, or less than or equal to 10%, as the balloon is inflated from its nominal inflation pressure to its rated burst pressure.

264. 264. The device of claim 263, wherein the polymer balloon comprises at least one of nylon, polyamide block copolymer, and polyethylene terephthalate (PET).

265. The device of claims 257-264, wherein at least some of the stiffening features are distributed across at least a portion of both the distal transition region and the proximal transition region of the outer surface of the expandable polymer balloon.

266. The device of claims 257-265, wherein at least some of the stiffening features are also distributed across at least a portion of both the tapered distal region and the tapered proximal region of the outer surface of the expandable polymer balloon.

267. The device of claims 257-266, wherein at least some of the stiffening features are distributed across at least a portion of both the proximal and distal 1 mm lengths of the central region of the outer surface of the expandable polymer balloon.

268. The device of claims 257-267, wherein the stiffening features are arranged in circumferential bands across the outer surface of the expandable polymer balloon.

269. 269. Apparatus according to claim 268, wherein the circumferential bands each include 2 to 8 rigidity features, typically 2 to 6 rigidity features, preferably 3 to 5 rigidity features.

270. The device described in claims 257-269, wherein some of the stiffening features are distributed throughout a central region of the outer surface of the expandable polymer balloon, and additional features are distributed throughout one or more of: (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, and (d) the proximal tapered region.

271. 271. The apparatus of claim 270, wherein all rigidity features have the same shape and dimensions.

272. The device of claim 270, wherein the rigidity features on the central region have a shape and / or dimensions that are different from the shape and / or dimensions of the rigidity features on one or more of: (a) the distal transition region, (b) the proximal transition region, (c) the distal tapered region, and (d) the proximal tapered region.

273. The device of claims 257-272, wherein the stiffening features are arranged in axial strips and circumferential bands in any or all of the regions.

274. 274. The apparatus of claim 273, wherein each axial strip consists of 2 to 8 rigid features.

275. An apparatus as described in claims 273 and 274, wherein each axial strip consists of 2 to 8 rigid features.

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